Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and Registration

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 803 and 807

[Docket No. 91N-0295]

RIN 0910-AA09

Medical Devices; Medical Device User Facility and Manufacturer

Reporting, Certification and Registration

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; opportunity for comments.

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SUMMARY: The Food and Drug Administration (FDA) is issuing regulations

requiring medical device user facilities and manufacturers to report

adverse events, related to medical devices, under a uniform reporting

system. This regulation is mandated by the Safe Medical Devices Act of

1990 (SMDA) and prescribes the conditions under which reports must be

submitted, the content and timing of the requisite reports, and how FDA

will utilize the information in carrying out its public health

protection responsibilities. This rule is intended to augment the

agency's postmarket surveillance activities and public health

protection responsibilities relating to medical devices.

In the future, FDA will propose to revoke the distributor adverse

event reporting regulations that went into effect on May 28, 1992, by

operation of law and replace them with provisions based on notice and

comment. FDA will also propose to fully implement its authority under

the Medical Device Amendments of 1992 (the 1992 amendments).

DATES: This final rule is effective April 11, 1996. Submit written

comments, as requested elsewhere in this document by, January 10, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Earl W. Robinson, Center for Devices

and Radiological Health (HFZ-530), Food and Drug Administration, 1350

Piccard Dr., Rockville, MD 20850, 301-594-2735.

SUPPLEMENTARY INFORMATION: On November 26, 1991 (56 FR 60024), FDA

published a tentative final rule implementing the user and distributor

reporting provisions of the SMDA (hereinafter referred to as the

November 1991 tentative final rule). The agency received over 300

comments in response to the tentative final rule, which are carefully

evaluated and responded to in this final rule. The final rule also

reflects the superseding reporting standard mandated by the Medical

Device Amendments of 1992.

I. Highlights of the Final Rule

This final rule provides FDA with increased post-market

surveillance information by requiring medical device user facilities

and manufacturers to report adverse event information as follows:

(a) Medical device user facilities must submit a medical device

report (MDR) to the device manufacturer within 10 days after becoming

aware of a reportable death or serious injury (including serious

illness). If the event involves a device-related death, or if the

identity of the device manufacturer is not known, the report must be

sent to FDA. User facilities must also submit a semiannual summary of

reports to FDA.

(b) Device manufacturers must submit MDR reports to FDA within 30

days after becoming aware of a reportable death, serious injury, or

malfunction.

(c) Device manufacturers must annually certify the number of MDR

reports filed with FDA during the preceding year.

(d) Upon receiving information about an MDR reportable event,

device manufacturers must submit a ``5-day report'' to FDA, within 5

work days of: (1) Becoming aware that a reportable event or events,

from any information, including any trend analysis, necessitates

remedial action to prevent an unreasonable risk of substantial harm to

the public health; or (2) becoming aware of an MDR reportable event

from which FDA has made a written request for the submission of a 5-day

report.

(e) A device manufacturer is responsible for reporting MDR events

related to its devices, whether or not the devices are still being

marketed by the firm. If a manufacturer receives information about an

event involving a device incorrectly identified as one marketed by that

firm, the information received must still be forwarded to FDA, with an

explanation that the device was misidentified.

In finalizing this regulation, FDA has worked to meet the

significant challenges of devising an effective medical device adverse

event reporting system while balancing industry concerns with public

health needs and statutory imperatives. The agency has also taken steps

to minimize the administrative costs and paperwork burdens that will

inevitably result for FDA, the medical device industry, and the device

user community. FDA is keenly aware of and sensitive to the impacts of

these new regulatory requirements on the pace of technological

advancement and economic well-being of the medical device industry. At

the same time, the agency is cognizant of the usefulness of information

about the clinical performance of medical devices in fulfilling its

public health mandate.

In striving to achieve regulatory balance, the agency carefully

analyzed over 300 public comments submitted in response to the November

1991 tentative final rule, and resolved policy and legal issues arising

from the comments and internal deliberations. This review of comments,

combined with an economic threshold analysis, and other agency studies

and deliberations, resulted in a number of major modifications that

will facilitate compliance with the final reporting requirements and

substantially reduce the overall costs, by an estimated $31 million,

borne by device user facilities, the device industry, and the agency.

These modifications are as follows:

(a) The agency has eliminated certain criteria from the previously

proposed manufacturer monthly reports including: An evaluation

consisting of a narrative description of the results of statistical

trend analyses conducted by the manufacturer, a discussion of the

underlying methodologies used, a description of any unusual or

unexpected events, and a description of any remedial actions taken.

FDA believes that the benefits of the proposed mandatory trend

analyses were not commensurate with the attendant costs to industry.

Upon further review, the agency has determined that it would incur the

costs of data entry regardless of the industry's analysis, and

operating a computer program for the analysis of the data would be a

relatively low cost to the agency. The proposed requirements for other

information that the final regulation is not adopting will still be

made available to the agency under the existing current good

manufacturing practice (CGMP) regulations (21 CFR part 820), and under

proposed 21 CFR part 806, reports of removals and corrections (59 FR

13828, March 23, 1994).

(b) The final regulation's reporting timeframe is shorter than the

timeframe proposed. Earlier access to adverse event information will

help the agency better to protect the public health.

(c) The agency has eliminated the proposed training and educational

requirements, which would have been particularly costly to user

facilities,

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because the projected costs substantially exceeded expected benefits.

This change will provide a net estimated annual cost saving of $29.1

million.

(d) The proposed imminent hazard report deadline has been extended

from 3 days to 5 days, and renamed a 5-day report. This extended

reporting timeframe should provide a more realistic opportunity for the

manufacturer to conduct a preliminary investigation regarding the

event. Any information not available for submission on the 5-day report

must be submitted in a supplemental report.

(e) The agency has developed reporting forms for baseline reports,

semiannual reports, and annual certifications. This action will

streamline the reporting procedure because industry will not be

required to format its own reports. The standardized report forms and

associated standardized electronic reporting formats will facilitate

the input of information submitted into FDA's data base. This more

efficient data processing will increase the agency's capacity to

respond to critical device- related problems by permitting more rapid

data analysis, leading to appropriate corrective measures.

(f) The agency has adapted its MDR systems and reporting

requirements in order to use the MEDWATCH form for reporting individual

adverse events. In so doing, FDA has eliminated a number of proposed

reporting elements, including the ``degree of certainty'' associated

with a reportable event, the ``medical status of patients'' involved in

device-related incidents, product ``service and maintenance,'' etc. The

adoption of the MEDWATCH reporting form streamlines the reporting

process and reduces the amount of information reporters must submit to

FDA.

(g) The agency has clarified that user facilities must report only

information that is reasonably known to them, and are not required to

investigate adverse events.

(h) The agency has devoted much time and effort to accommodate

electronic reporting. The agency is in the process of developing

formats, guidelines, and procedures for electronic reports which, when

available, will obviate the need for written agency approval for the

use of electronic submissions.

(i) In response to comments, the agency has clarified a number of

the definitions included in the proposed rule and added new definitions

to enhance clarity. The agency also substantially altered the

organization and the paragraph designations of the final rule to

provide information in the clearest and most usable form in part 803

(21 CFR part 803).

Revised part 803 has been subdivided into five subparts. Subpart A

contains general provisions including sections for the scope,

definitions, public availability of reports, and general reporting and

record requirements.

Subpart B of revised part 803 contains generally applicable

reporting requirements for individual adverse event reports. Specific

requirements for individual adverse event reports, and other reports

required by user facilities and manufacturers, are in subparts C and E,

respectively. Each subpart divides the reporting requirements for each

type of reporting entity into separate sections that are organized to

improve readability. The agency believes that the new organization of

the regulation provides clearer guidance to industry than the 1991

tentative final rule.

II. Background

Under the Federal Food, Drug, and Cosmetic Act of 1938 (21 U.S.C.

301-394) (the act), and the Medical Device Amendments of 1976 (Pub. L.

94-295) (the 1976 amendments), FDA issued medical device reporting

regulations for manufacturers (49 FR 36326 at 36348, September 14,

1984). To correct weaknesses noted in the 1976 amendments, and to

better protect the public health by increasing reports of device-

related adverse events, Congress enacted the SMDA (Pub. L. 101-629),

which required medical device user facilities, and distributors to

report certain device-related adverse events. In response to a

directive in the SMDA, FDA issued the November 1991 tentative final

rule proposing to implement regulations concerning reporting of adverse

events related to devices by user facilities and distributors. In the

November 1991 tentative final rule, FDA also proposed to amend the

existing manufacturer reporting regulations to conform to the proposed

user facility and distributor reporting requirements.

A. User Facility, Manufacturer and Distributor Reporting Requirements

Under the SMDA

The SMDA added section 519(b)(1) to the act (21 U.S.C. 360i(b)(1))

to require that certain user facilities (hospitals, nursing homes,

ambulatory surgical facilities and outpatient treatment facilities)

report certain adverse events. The SMDA also authorized FDA to require

diagnostic outpatient facilities to submit reports. Under the SMDA,

user facilities must report device-related deaths to FDA and to the

manufacturer. They must also report serious illnesses and injuries to

the manufacturer, or to FDA if the manufacturer's identity is unknown.

Reports must be made as soon as practicable, but no later than 10

working days after the user facility becomes aware of a reportable

event. In addition to individual adverse event reports, the SMDA

requires each user facility to submit to FDA, on a semiannual basis, a

summary of the reports it has submitted to FDA and to manufacturers.

The provision in section 519(b) of the act that requires user

facilities to report adverse events became effective by operation of

law on November 28, 1991.

In addition to requiring reporting by user facilities, the SMDA

added section 519(a)(6) (subsequently redesignated as 519(a)(9) by the

1992 amendments) to the act to require FDA to issue regulations

regarding distributor reporting of adverse device events. The SMDA also

added section 519(d) to the act to require both manufacturers and

distributors to certify to FDA either the number of reports submitted

in a year or that no such reports were submitted to the agency.

Distributor reporting requirements became effective on May 28,

1992, when the provisions relating to distributor reporting in the

November 1991 tentative final rule became final by operation of law. In

the Federal Register of September 1, 1993 (58 FR 46514), FDA published

a notice announcing that the proposed distributor reporting regulations

had become final by operation of law on May 28, 1992, and that these

regulations had been amended by certain provisions of the 1992

amendments discussed below.

In the Federal Register of September 1, 1993, FDA also published a

final rule, based on the November 1991 tentative final rule, requiring

distributors to register and list their devices (58 FR 46514).

Distributor registration and listing requirements became effective on

October 1, 1993.

In a future rulemaking, FDA will propose in the Federal Register to

revoke the distributor regulation that went into effect by operation of

law and replace it with provisions based on notice and comment.

B. User Facility, Manufacturer and Distributor Reporting Requirements

Under the Medical Device Amendments of 1992

Subsequent to FDA's issuance of the November 1991 tentative final

rule to require adverse event reporting by user facilities,

distributors, and manufacturers, on June 16, 1992, the President signed

into law the 1992

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amendments (Pub. L. 102-300), amending certain provisions of section

519 of the act relating to reporting of adverse device events. In the

future, FDA will publish a proposed rule to fully implement its

authority under the 1992 amendments. A summary of these changes

follows:

1. Adoption of a Single Reporting Standard

Section 5(a) of the 1992 amendments adopts a single standard to

specify when injuries caused by devices must be reported to FDA.

Manufacturers and importers are required to report a device-related

adverse event to FDA whenever they receive or otherwise become aware of

information that reasonably suggests that one of their marketed devices

may have caused or contributed to a death or serious injury, or has

malfunctioned and that such device or a similar device marketed by them

would be likely to cause or contribute to a death or serious injury if

the malfunction were to recur.

Similarly, section 5(a) of the 1992 amendments revises the

reporting requirements to require a user facility to report whenever

the facility receives or otherwise becomes aware of information that

reasonably suggests that a device ``has or may have caused or

contributed'' to the death, serious illness or serious injury of a

patient of the facility.

2. Single Definition of Types of Injuries That Must Be Reported

Section 5(a) of the 1992 amendments also adopted a single

definition for the types of injuries that user facilities,

manufacturers, importers, and distributors must report. This definition

requires reporting of an injury or illness that is: (1) Life-

threatening; (2) results in permanent impairment of a body function or

permanent damage to a body structure; or (3) necessitates medical or

surgical intervention to preclude permanent impairment of a body

function or permanent damage to a body structure. This definition

differs from the previous statutory definition of ``serious injury'' or

``serious illness'' in the user facility provisions and the definition

in the November 1991 tentative final regulation. The new definition

deleted the requirement that an injury must require immediate

intervention to preclude permanent impairment or damage in order to

qualify as a reportable adverse event.

3. New Authority To Require Reporting of ``Other Significant Adverse

Device Experiences''

The 1992 amendments also authorized FDA to issue regulations

requiring user facilities, manufacturers, importers, and distributors

to report ``significant adverse device experiences'' that the agency

determines are necessary to be reported, other than deaths, serious

injuries or serious illnesses, that might otherwise not fall within the

definitions of reportable deaths, serious injuries, or malfunctions.

III. Reporting Forms

A. Individual Adverse Event Reports by User Facilities and

Manufacturers

Under Secs. 803.30 and 803.50, user facilities and manufacturers

are required to submit device-related reports of individual adverse

events on FDA Form 3500A or an FDA approved electronic equivalent. In

order to simplify and consolidate reporting of adverse events, FDA

announced in the Federal Register of February 26, 1993 (58 FR 11768)

the availability of a new single ``MEDWATCH'' form for reporting

adverse events and product problems with devices, drugs, biologics,

special nutritional products and other products regulated by the agency

(hereinafter referred to as the February 1993 notice). In response to

FDA's request for comments on the form in the Federal Register, 79

comments were submitted by medical device trade associations and other

regulated or affected entities. On June 3, 1993 (58 FR 31596), after

consideration of these comments, FDA published the final reporting

form. (The form is described in Sec. 803.10.)

B. Annual Certification by Manufacturers

Under Sec. 803.57, manufacturers must also submit at the time of

their annual registration a completed FDA Form 3381 or an FDA approved

electronic equivalent, certifying: (1) That all reportable events were

submitted; (2) the number of reports submitted; or (3) that no reports

were submitted during the previous 12-month period.

C. Semiannual Summaries by User Facilities

Under Sec. 803.33, user facilities are required to submit, on FDA

Form 3419 or an FDA approved electronic equivalent, a semiannual

summary of all events reported during the prior reporting period.

Semiannual reports must include information regarding the user

facility, device manufacturers, products, and a brief description of

the events.

D. Baseline Reports

Under Sec. 803.55, manufacturers must submit baseline reports, on

FDA Form 3417 or an FDA approved electronic equivalent, simultaneously

with the submission of the first event report for each device. These

reports, which are to be updated annually, must contain information on

the manufacture and distribution of the relevant devices.

E. Effective Date of the Reports

Adverse event reports and other related reports required by this

regulation must be submitted using the appropriate forms or approved

electronic equivalents, after April 11, 1996.

IV. Summary and Analysis of Comments and FDA's Response

This final rule is based on FDA's analysis of the over 300 comments

that the agency received in response to the November 1991 tentative

final rule, and it conforms to certain statutory revisions in the 1992

amendments. This final rule reflects actions in two areas. First, it

revises the manufacturer reporting regulations that have been in effect

since 1984. Second, it implements the statutorily directed user

facility reporting requirements that have been in effect since November

28, 1991.

Originally, FDA gave interested persons until January 27, 1992, to

comment on the November 1991 tentative final rule. In the Federal

Register of January 24, 1992 (57 FR 2861), FDA extended the comment

period until February 26, 1992. A summary of the comments and FDA's

responses follow:

A. Section 803.1--Scope

1. Several comments stated that the proposed regulation exceeds the

SMDA and has no statutory authority. Many comments stated that the

scope of the provisions was overly broad, and would increase the

burdens, with unclear benefits, on all parties involved.

The agency disagrees. Section 519 of the act, as amended by the

SMDA and the 1992 amendments, provides clear authority to issue this

regulation. Section 519 of the 1976 amendments granted FDA the

authority to issue regulations to require manufacturers to maintain

such records, make such reports, and provide such information to FDA as

may reasonably be necessary to ensure that devices are not adulterated

or misbranded and are otherwise safe and effective for human use. The

legislative history of the 1976

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amendments reflects clear congressional intent to permit FDA to

require, under the authority of section 519 of the act, manufacturers

to report to FDA product defects and adverse effects of the firms'

devices. (See H. Rept. 853, 94th Cong., 2d Sess. 23 (1976).)

Among other things, section 519 of the act states that any

reporting requirement established under the authority of that section:

(1) May not be unduly burdensome (considering the cost of compliance

and the need for the requirement); (2) shall state the purpose for any

required report or information and identify to the fullest extent

practicable such report or information; (3) may not, except in certain

circumstances, require the disclosure of a patient's identity; and (4)

may not, except in certain circumstances, require the manufacturer of a

class I device to maintain records or to submit information not in its

possession, unless such report or information is necessary to determine

whether a device is misbranded or adulterated. The House Report

cautions, however, that these limitations ``should not be construed as

limiting the Secretary's authority to obtain information needed to

insure that the public is protected from potentially hazardous

devices.'' (Id.) In its discussion of section 519 of the act, the House

Report lists examples of reasonable reporting requirements, including

reports of defects, adverse reactions and patient injuries. It is also

clear from the legislative history that Congress intended FDA to use

its authority under section 519 of the act to protect the public from

potentially hazardous devices, as well as from devices with confirmed

hazards. (Id.)

Since enactment of the 1976 amendments, Congress has focused

considerable attention on FDA's implementation and enforcement of the

act. Congress concluded that the 1976 amendments were not always

adequate to protect the public health. (H. Rept. 808, 101st Cong., 2d

Sess. 13-14 (1990); S. Rept. 513, 101st Cong., 2d Sess. 13-16 (1990).)

To correct these problems, Congress passed and the President, on

November 28, 1990, signed into law the SMDA, which amended the medical

device provisions of the act.

The SMDA added section 519(b)(1) to the act to require that certain

user facilities (e.g., hospitals, nursing homes, ambulatory surgical

facilities, and outpatient treatment facilities) report deaths related

to medical devices to FDA, as well as to the manufacturer if the

manufacturer's identity is known. Section 519(b)(5)(A) of the act also

provides FDA with authority, which FDA has exercised in this final

regulation, to include outpatient diagnostic facilities in this

requirement. Serious illnesses and injuries are to be reported to the

manufacturer, or to FDA if the manufacturer's identity is not known.

Reports must be made as soon as practicable but no later than 10

working days after the user facility becomes aware of an event. The

responsibility for reporting is limited to events involving patients

and employees of the facility. Each device user facility is also

required to submit to FDA, on a semiannual basis, a summary of reports

it has submitted to both FDA and manufacturers.

Section 519(d) of the act, as added by the SMDA, also requires

manufacturers to certify to FDA the number of reports submitted in the

preceding 12-month period or, alternatively, certify that no such

reports have been submitted to the agency during the same period. FDA

believes that section 519 of the act, as amended by the SMDA and the

1992 amendments, provides clear authority to issue this regulation for

manufacturers and user facility reporting.

Moreover, FDA does not believe that the provisions of this

regulation are overly broad or unduly burdensome. FDA has reviewed and

revised the regulation to clarify and limit the scope as appropriate.

FDA believes that certain classes of persons, which might otherwise fit

within the definition of manufacturer, should be exempt from the

reporting requirements because reports from these persons are not

necessary to ensure that the device is not adulterated or misbranded,

and the device is otherwise safe and effective. Accordingly under

Sec. 803.19, dental laboratories and optical laboratories have been

exempted from the reporting requirements. FDA believes that these

entities are not likely to receive reports of device-related deaths,

serious injuries, or reportable malfunctions. In addition, requiring

negative annual certification reports from these entities would be

burdensome and not provide significant benefit to the public health.

Therefore, FDA is excluding such entities from the reporting

requirements. Other specific revisions are discussed in detail

throughout this document.

FDA believes this regulation carefully balances the interests of

public health with industry burdens by limiting the required

information to only that which is necessary to evaluate risks

associated with medical devices and that it will enable the agency

better to take appropriate regulatory measures to protect the public

health. Furthermore, FDA does not believe that the burden on reporting

entities will be significant. Based upon the number of reports FDA has

received since the publication of the November 1991 tentative final

rule, the agency anticipates that it will receive approximately 150,000

reports the first year of this reporting program (the agency currently

receives over 100,000 reports annually).

2. Several comments pointed out that these provisions go beyond the

scope of the SMDA in that the timeframes for reporting adverse events

exceed the requirements of SMDA. Other comments argued that all

employees of reporting entities should not be included under the

reporting requirements of the SMDA, and that accordingly, the

timeframes for reporting should not be triggered upon the knowledge of

``any employee'' of a reporting entity.

FDA does not agree that the regulation's 10-day reporting

timeframes for user facilities and 5-day and 30-day reporting

timeframes for manufacturers are beyond the scope of the SMDA. Section

519(b)(1)(A) of the act specifies that user facilities must report

certain adverse events as soon as practicable, but not later than 10

work days after becoming aware of the information. This section further

specifies that FDA has the discretion to prescribe, by regulation, a

shorter reporting period. While the statute does not specify the time

periods allowed to manufacturers, the timeframes are consistent with

section 519 of the act, the legislative history and FDA's public health

responsibility to require that the reports are forwarded to the agency

in a timely manner. FDA believes the time periods prescribed in the

final regulation allow sufficient time for reporting entities to gather

information, and are sufficiently time sensitive to allow the agency to

respond rapidly and appropriately to protect the public health.

FDA also does not agree that employees of reporting entities should

not be subject to the reporting requirements and that timeframes for

reporting should not be triggered when employees of the reporting

entities become aware of events. The scope of the act does not exclude

any responsible persons who are employees of these entities from

complying with section 519 of the act.

Under the final regulation, the reporting periods are based upon

the time at which the reporting entity becomes aware of the reportable

event. FDA believes that the final regulation's definition of ``becomes

aware'' in Sec. 803.3(c) properly defines the types of user facility

and manufacturer employees who must become aware of a reportable event

in order to trigger the reporting requirement. FDA believes

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that it will be feasible for user facilities and manufacturers to train

the employees, described below, to be familiar enough with the

obligation to report adverse events immediately to the appropriate

person that the manufacturer or user facility designates as responsible

for MDR reporting.

Under Sec. 803.3(c), a device user facility is deemed to have

``become aware'' when medical personnel of a facility become aware of a

reportable event. ``Medical personnel'' are defined in Sec. 803.3(r) as

individuals who are licensed, registered, or certified to administer

health care; individuals with professional or scientific degrees;

individuals who are responsible for receiving medical complaints or

adverse event reports; or supervisors of such persons. FDA believes

that a user facility can easily notify these types of employees about

their obligation to immediately forward possible device-related adverse

events to the appropriate person designated by the hospital to submit

such reports.

FDA believes that manufacturers have a direct responsibility to

inform all employees to immediately forward adverse event information

to the appropriate person appointed by those entities to submit MDR

reports. Accordingly, FDA generally considers that a manufacturer

becomes aware of an adverse event whenever any employee becomes aware

of an adverse event. The one exception is for 5-day reports under

Sec. 803.53(b), which requires manufacturers to submit a report when

the manufacturer becomes aware of information that an adverse event or

events necessitate remedial action to prevent an unreasonable risk of

substantial harm to the public health.

Under Sec. 803.53, manufacturers must submit a 5-day report under

two different circumstances. The first type of 5-day reporting

obligation arises after a manufacturer has received a written request

from FDA for 5-day reports for specific types of adverse events. Under

this circumstance, a 5-day report must be submitted when any employee

becomes aware of an adverse event. FDA believes that the awareness of

any employee should trigger the reporting requirement when FDA has

informed the manufacturer of the need for specific adverse events that

require 5-day reports because the manufacturer could easily inform all

of its employees of FDA's request.

The second type of 5-day report does not involve a direct request

from FDA and is required only when the manufacturer becomes aware that

an event or events necessitate remedial action to prevent an

unreasonable risk of substantial harm to the public health.

Accordingly, this type of 5-day reporting requirement would only arise

if remedial action were required, and the remedial action is necessary

to prevent an unreasonable risk of substantial harm to the public

health. If no remedial action is required, or the remedial action is

taken but it is not necessary to prevent an unreasonable risk to the

public health, reportable adverse events should be submitted as 30 day

reports.

Because FDA does not believe certain employees, such as non-

technical staff, would be able to recognize that an adverse event or

events may require remedial action to prevent a substantial risk to the

public health, the final regulation requires that these types of 5-day

reports be submitted only when employees holding certain positions of

responsibility become aware of adverse event information. Accordingly,

the final regulation considers a manufacturer to be aware of this type

of 5-day report only when an employee with management or supervisory

responsibilities over persons with regulatory, scientific, or technical

responsibilities, or a person whose duties relate to the collection and

reporting of adverse events, becomes aware that a reportable MDR event

or events necessitate remedial action to prevent an unreasonable risk

of substantial harm to the public health. FDA believes that limiting

the type of person who must be aware of the adverse event to these

types of individuals is appropriate because persons in these positions

should be able to recognize that the event or events may present

significant risks to the public health.

3. Some comments suggested limiting the scope of these provisions

so that reporting is required only when there is a death or serious

injury. Other comments suggested that reports not be required if the

device was only indirectly responsible for a death or serious injury,

or was not a significant factor. Another comment suggested that

reporting be limited to instances of malfunction.

Section 519 of the act provides FDA with authority to require

reporting of adverse events other than deaths or serious injuries. FDA

has exercised this authority since 1984 by requiring manufacturers to

report certain malfunctions. Moreover, section 519(a)(1) of the act (as

amended by section 5 of the 1992 amendments) specifically states FDA's

adverse event reporting regulations must require manufacturers to

report malfunctions if the recurrence of the malfunction would be

likely to cause a death or serious injury, regardless of whether an

actual death or injury occurs. Because devices with such malfunctions

pose significant risks, FDA needs to be informed of these incidents.

The final regulation, therefore, requires manufacturers to report

malfunctions when recurrence would be likely to cause a death or

serious injury. User facilities are encouraged but not required to

report malfunctions to manufacturers and distributors.

Section 519(b)(1)(B)(ii) of the act, as added by the 1992

amendments, also provides FDA with authority to require user

facilities, distributors, and manufacturers to report other significant

adverse device experiences that FDA determines necessary. Therefore, in

a future issue of the Federal Register, FDA will propose to require

that certain events be reported as significant adverse device

experiences. Although some of these experiences may not have caused

harm, FDA believes such events should be reported because of the

potential risk to the public health if the event were to recur. Such

information will enable the agency to take appropriate measures to

prevent such recurrences.

FDA also disagrees with the comments stating that reporting should

be required only when a device directly causes an adverse event or is a

significant factor. Section 519(a)(1) and (b)(1)(A) of the act requires

reporting of any adverse event when information reasonably suggests

that a marketed device ``may have caused or contributed'' to a

reportable event (emphasis added). Limiting reporting to adverse events

directly or significantly caused by devices would narrow the statutory

reporting standard which requires reporting of adverse events when a

device ``may have caused or contributed'' to an adverse event (emphasis

added).

FDA cannot agree with the comment that suggested reporting be

limited to instances of malfunction. As stated above, section 519 of

the act requires reporting of deaths and serious injuries, and

authorizes FDA to require reporting of other significant adverse device

experiences, as well as malfunctions.

FDA does not agree with the comments that reporting should not be

required when events are anticipated or intrinsically caused by the

device. The statute does not exempt events that were anticipated or

intrinsically caused by the device. (See section 519(a) (1) and

(b)(1)(B) of the act.) Moreover, merely knowing that adverse events are

anticipated or intrinsically caused by a device does not obviate the

need for information contained in event reports.

[[Page 63583]]

FDA needs to know the frequency and severity of adverse events in order

to take appropriate action.

4. One comment objected to providing warranty information. Other

comments stated that a manufacturer's responsibility to report should

end at the expiration of the warranty.

The agency disagrees. Reporting requirements under section 519 of

the act are not restricted or limited in any way by manufacturer

warranties. Section 519 of the act requires manufacturers to report

certain adverse events regardless of whether the warranty has expired.

Warranties are private contracts between the purchaser and the

manufacturer. In order to protect the public health and determine

whether actions should be taken with respect to a device associated

with an adverse event, FDA must receive information regarding all

reportable events, including those that occur after a manufacturer's

warranty has expired.

5. One comment stated that certain adverse events may result from

the user not knowing how to properly use the device, and that this

would lead to the reporting of events properly attributable not to the

device, but to its incorrect use.

As with the 1984 manufacturer adverse event reporting regulation,

this rule requires reports of certain adverse device events caused by

user error. Device injuries attributed to user error may indicate that

the device is misbranded within the meaning of section 502(f) of the

act (21 U.S.C. 352(f)) in that the device fails to bear adequate

directions for use or adequate warnings. In such cases, reports of

adverse events that result from user error may alert FDA to the need

for improved labeling to prevent future injuries.

6. One comment suggested that independent device service personnel

be added to the list of people required to report because some

manufacturers may not receive reports from their own service personnel.

Under section 519 of the act, only user facilities, manufacturers,

and distributors are required to report adverse events to FDA. User

facilities are considered to have ``become aware'' of such information

whenever any medical personnel becomes aware of a reportable event.

Manufacturers are considered to have ``become aware'' of events

required to be reported in 30 days, or required to be reported in 5

days, pursuant to an FDA request, when any employee becomes aware of an

adverse event. Manufacturers are considered to have become aware of

significant risk 5-day reports, which are more fully described in

IV.A., comment 2, of this document, only when certain higher level

employees become aware of adverse events requiring remedial action.

FDA believes that an employee of a manufacturer includes

independent service personnel who are contracted by manufacturers to

service their medical devices. It is the responsibility of

manufacturers to ensure that their service personnel, whether staff

employees or under contract, are informed of the requirement to report

deaths, serious injuries, malfunctions, or other significant adverse

device experiences that may be required by regulation in the future.

B. Section 803.3--Definitions

7. Many comments stated that the definition of ``device family''

(Sec. 803.3(e)) that is used to identify similar groups of devices on

the manufacturer baseline report, is vague and overly broad. One

comment suggested that each device be listed in the regulation; others

suggested that the definition be deleted.

FDA does not agree that the definition should be deleted. The

identification of the device family on the baseline reports for

individual device models will help FDA and manufacturers group similar

models for analysis. This will aid in identifying the causation and

nature of device-related problems. FDA agrees, however, that the

definition should be clarified and has revised it accordingly.

Manufacturers may use their own methods of grouping devices if the

groupings meet the definition of ``device family,'' i.e., the devices

have the same basic design and performance characteristics related to

safety and effectiveness, intended use and function, and device

classification and product code. FDA has the discretion to determine

the appropriateness of a manufacturer's determination of the devices

that comprise a device family. It would be impractical to list each

device in the regulation.

8. Many comments stated that the definition of ``device user

facility'' (Sec. 803.3(f)) is vague. Several of these comments

requested clarification regarding what facilities are included in the

definition. Several comments suggested that certain groups (i.e., blood

banks, independent rescue squads, school clinics or nurse offices,

employee health units, dental offices and free-standing care units

operating as private physician offices) be specifically included or

excluded from the definition.

FDA agrees in part. Under section 519(b)(5)(A) of the act, FDA has

exercised its discretion to include outpatient diagnostic facilities

that are not physician offices in the definition of ``device user

facility.'' Under Sec. 803.3(f), device user facility means ``a

hospital, ambulatory surgical facility, nursing home, or an outpatient

diagnostic or treatment facility which is not a physician's office.''

To further clarify this definition, FDA has included definitions for

the terms ``physician's office'' (Sec. 803.3(w)), ``hospital''

(Sec. 803.3(l)), ``ambulatory surgical facility,'' (Sec. 803.3(b)),

``nursing home'' (Sec. 803.3(s)), ``outpatient diagnostic facility''

(Sec. 803.3(t)), and ``outpatient treatment facility'' (Sec. 803.3(u)).

Under section 519(b)(5)(A) of the act, physicians' offices are

excluded from the definition of user facilities and are thereby

excluded from adverse event reporting requirements. FDA believes that

groups performing functions similar to physicians' offices such as

dental offices and offices of other health care practitioners (e.g.,

chiropractors, optometrists, nurse practitioners, school nurse offices,

employee health clinics, free-standing care units) fall within the

definition of ``physician's office'' and therefore should be excluded

from reporting. FDA invites further public comment on the definition of

``physician's office'' and may issue further guidance as necessary.

FDA has defined ``outpatient treatment facility'' as a distinct

entity that operates for the primary purpose of providing non-surgical

therapeutic care. FDA believes that ambulance or rescue squad services

and independent home health care agencies fall within this definition.

Given the critical risks posed by potential malfunctions of devices

used by ambulance services and in home health care settings, FDA

believes the inclusion of these services within the definition of

``outpatient treatment facility'' is appropriate.

Blood banks that operate in hospitals or as outpatient treatment or

outpatient diagnostic centers fall within the definition of user

facility. Accordingly, device-related adverse events that meet the

definition of MDR reportable event, as defined in Sec. 803.3(q), that

occur in such blood banks must be reported. FDA invites further public

comment on the definition of user facility and may issue further

guidance as necessary.

9. Several comments stated that the definition of ``imminent

hazard'' relating to types of adverse events that FDA proposed should

have 3-day reporting timeframes (proposed Sec. 803.3(g)) is unclear. A

few comments suggested that the definition be deleted because it is too

subjective, belongs in another regulation, or is beyond the scope of

the SMDA. Some comments

[[Page 63584]]

stated that more than 3 days were needed for reporting.

FDA agrees. The agency is extending the time period to make such

reports from 3 days to 5 days. FDA is also renaming ``imminent hazard

reports'' as ``5-day reports'' (defined in Sec. 803.3(k)), and has

clarified this requirement in Sec. 803.53.

The purpose of the 5-day report is to alert the agency rapidly to

adverse events that may pose an unreasonable risk of substantial harm

to the public health. Thus, the definition of ``5-day report'' has been

revised to mean a report of an adverse event required by a

manufacturer, submitted on FDA Form 3500A or an FDA approved electronic

equivalent within 5 work days of: (1) Any employee, who is a person

with management or supervisory responsibilities over persons with

regulatory, scientific, or technical responsibilities, or a person

whose duties relate to the collection and reporting of adverse events,

becoming aware that a reportable MDR event or events, from any

information, including any trend analysis, necessitates remedial action

to prevent an unreasonable risk of substantial harm to the public

health; or (2) any employee becoming aware of an adverse event, if the

manufacturer has received a written request from FDA for the submission

of a 5-day report for those types of adverse events. When such a

request is made, the manufacturer shall submit a 5-day report for all

subsequent adverse events of the same nature that involve substantially

similar devices for the time period specified in the written request.

The time period stated in the original written request can be extended

by FDA if it is in the interest of the public health.

FDA does not intend that a manufacturer delay or interrupt a

remedial action in order to submit a 5-day report. The report must be

made within 5 days of the manufacturer becoming aware that a reportable

event or events necessitate remedial action to prevent unreasonable

risk of substantial harm to the public health. Information that would

reasonably suggest remedial action is necessary to prevent such risk

may, for example, be from one MDR reportable event that makes the

manufacturer aware of a serious design flaw that necessitates remedial

action to prevent an unreasonable risk of substantial harm to the

public. On the other hand, information that would reasonably suggest

remedial action is necessary may result from an internal trending

analysis of several MDR reports that make the manufacturer aware that

serious injuries or deaths occur at a much higher frequency than

expected. Further discussion relating to when a manufacturer is

considered aware of a reportable event is in section IV.A., comment 2,

of this document.

Manufacturers who submit 5-day reports are not required to submit

reports of removals and corrections under section 519(f) of the act.

Any information not available for reporting under the 5-day reporting

timeframe may be submitted in a supplemental report.

FDA does not agree with comments asserting that 5-day reports are

beyond the scope of the SMDA or belong in another regulation. Requiring

5-day reports is consistent with FDA's authority under section

519(a)(1) of the act to issue regulations requiring manufacturers to

report information that reasonably suggests that one of their marketed

devices ``may have caused or contributed to a death or serious injury,

or has malfunctioned and that such device * * * would be likely to

cause or contribute to a death or serious injury if the malfunction

were to recur.'' For the protection of the public health, FDA may limit

the time allowed to manufacturers for reporting events of which the

agency should be quickly aware.

10. Many comments stated that the requirements relating to user

facility incident files (proposed Sec. 803.35(c)) that contain

documents related to adverse events that a user facility must maintain

are overly burdensome because the definition of ``incident files'' in

proposed Sec. 803.3(h) is overly broad. Many of these comments

suggested that the definition of incident files be removed or changed

in order to clarify or limit the scope of requirements relating to the

files. Other comments suggested that FDA's access to the files be

limited.

The agency agrees that the definition of these files (which have

been renamed ``MDR event files'' in Sec. 803.18 of the final

regulation) could be narrowed. Accordingly, FDA has revised the

definition of MDR event files to include MDR reports filed with FDA or

other entities, and documents related to the adverse event, including

documents relating to deliberations and decisionmaking processes used

in the evaluation or determination of whether an event is an MDR

reportable event. The final rule also allows the reporter to

incorporate certain information by reference, such as medical records,

patient files, and engineering reports, rather than include them in the

MDR event file.

FDA does not agree that agency access to user facility files should

be limited. Under Sec. 803.18(b), user facilities shall permit any

authorized FDA employee during all reasonable times to have access to,

and to copy and verify the records required under part 803. FDA has

authority to inspect files under section 704(e) of the act (21 U.S.C.

374(e)). Section 704(e) of the act states that every person required to

maintain records under section 519 of the act, and every person who is

in charge or custody of such records, shall permit FDA at all

reasonable times to have access to and to copy and verify such records.

In issuing a regulation stating its authority under section 704(e) of

the act to have access to user facility adverse event files, FDA is

exercising its duty under the statute to protect the public health by

ensuring that user facilities comply with reporting requirements issued

under section 519 of the act.

11. Several comments stated that the definition of what kind of

information triggers the reporting requirements, specifically, the

definition of ``information that reasonably suggests that there is a

probability that a device has caused or contributed to a death or

serious injury, or serious illness'' (proposed Sec. 803.3(i)), is

unclear and requires further definition.

The agency agrees and has clarified this concept in Sec. 803.20(c).

As explained in section II.B.1 of this document, section 5 of the 1992

amendments revised section 519(a)(1) of the act, subsequent to FDA's

November 1991 tentative final rule, to require the agency to issue

regulations that require manufacturers and importers to report to FDA

``whenever the manufacturer or importer receives or otherwise becomes

aware of information that reasonably suggests that one of its marketed

devices: (1) May have caused or contributed to a death or serious

injury, or (2) has malfunctioned and that such device or a similar

device marketed by the manufacturer or importer would be likely to

cause or contribute to a death or serious injury if the malfunction

were to recur.'' Similarly, section 5 of the 1992 amendments revised

the reporting standard for user facilities under section 519(b)(1) (A)

and (B) of the act to require a user facility to submit a report

whenever it receives or otherwise becomes aware of information ``that

reasonably suggests that a device has or may have caused or contributed

to a death * * * or serious illness of, or serious injury to, a patient

of the facility * * *.''

Under the revised 1992 amendments' statutory reporting standards,

FDA has no discretion to change the reporting standards for

manufacturers and user

[[Page 63585]]

facilities. Accordingly, FDA has revised the wording of the reporting

standards in the final regulation for user facilities and manufacturers

to reflect the exact wording in the 1992 amendments for these entities.

Therefore, the final regulation requires user facilities and

manufacturers to report certain adverse events whenever there is

``information that reasonably suggests that a device may have caused or

contributed to a death or serious injury.''

The final rule describes, in Sec. 803.20(c) ``[i]nformation that

reasonably suggests that a device has or may have caused or contributed

to an MDR reportable event'' to be any information, such as

professional, scientific or medical facts and observations or opinions,

that would reasonably suggest that a device has caused or may have

caused or contributed to an MDR reportable event. Reports are not

required when there is information that would cause a person who is

qualified to make a medical judgment (e.g., a physician, risk manager,

or biomedical engineer) to reach a reasonable conclusion that a device

did not cause or contribute to an MDR reportable event. Information

that leads to the conclusion that an event is not reportable must be

retained in the MDR event files for the time periods specified in

Sec. 803.18.

The final rule further defines, in Sec. 803.3(d), ``caused or

contributed'' to mean that a death or serious injury was or may have

been attributable to a medical device, or that a medical device was or

may have been a factor in the adverse event including events occurring

as the result of its failure, malfunction, improper or inadequate

design, labeling, performance, manufacture, or user error. Devices may

cause or contribute to MDR reportable events either directly or

indirectly.

12. One comment stated that malfunctions of medical devices used

for a nonmedical purpose should be exempted. Other comments stated that

the term ``malfunction,'' as defined in Sec. 803.3(m), needed

clarification, especially with regard to implanted devices. Another

comment asked who is required to report implant malfunctions.

Under this final regulation in subpart E of part 803 manufacturers

must report certain malfunctions, including implant malfunctions, that

would be likely to cause or contribute to an MDR reportable event,

regardless of how the device is used. Although user facilities are not

required by statute or regulation to report malfunctions, FDA

encourages user facilities to report malfunction information to

manufacturers and distributors. Malfunction reports provide important

information to FDA concerning device safety.

Reporters do not need to assess the likelihood that a malfunction

will recur. The fact that the malfunction occurred once leads to the

presumption that the malfunction will recur. A malfunction is

reportable if any one of the following is true: (1) The chance of a

death or serious injury occurring as a result of a recurrence of the

malfunction is not remote; (2) the consequences of the malfunction

affect the device in a catastrophic manner that may lead to a death or

serious injury; (3) the malfunction results in the failure of the

device to perform its essential function and compromises the device's

therapeutic, monitoring or diagnostic effectiveness which could cause

or contribute to a death or serious injury, or other significant

adverse device experiences required by regulation (the essential

function of a device refers, not only to the device's labeled use, but

for any use widely prescribed within the practice of medicine); (4) the

malfunction involves a long- term implant or a device that is

considered to be life-supporting or life-sustaining and thus is

essential to maintaining human life; or (5) the manufacturer takes or

would be required to take an action under sections 518 or 519(f) of the

act as a result of the malfunction of the device or other similar

devices.

Malfunctions are not reportable if they are not likely to result in

a death, serious injury or other significant adverse device experience,

that FDA, in a future rulemaking, may require by regulation. A

malfunction which is or can be corrected during routine service or

device maintenance must be reported if the recurrence of the

malfunction would be likely to cause or contribute to a death or

serious injury, or other significant adverse device experiences

required by a future regulation.

13. Several comments stated that the definition of a

``manufacturer'' (Sec. 803.3(n)), who is subject to adverse event

reporting requirements, is overly broad with regard to custom devices

and devices modified by users. One comment suggested that the

definition be modified to include manufacture for commercial

distribution only.

FDA believes that for protection of the public health, the

definition should be broad enough to provide for reporting by all

persons engaged in the manufacture, preparation, propagation,

compounding, assembly or processing of medical devices, who may receive

information about adverse events related to medical devices, except

those manufacturers exempted under section 519(c) of the act and

Sec. 803.19. Under section 519(c) of the act and Sec. 803.19, a

practitioner licensed by law to prescribe or administer devices

intended for use in humans and who manufactures or imports devices

solely for use in the course of that individual's professional practice

is exempt from reporting. Manufacturers of devices not being

commercially distributed but which are being used under an

investigational device exemption are required to report adverse events

under parts 812 and 813 (21 CFR parts 812 and 813) and are not required

to submit reports under part 803. Parts 812 and 813, however, require

reporting of all adverse device effects.

14. Many comments stated that the definition of ``MDR reportable

event'' (Sec. 803.3(q)) is unclear, beyond the scope of SMDA, or

otherwise in need of revision.

The definition of ``MDR reportable event'' has been modified to

conform to revisions made to section 519 of the act by section 5 of the

1992 amendments. As defined in Sec. 803.3(q), the revised definition of

``MDR reportable event'' mirrors the language of section 519(a)(1) and

(b)(1) of the act, as amended by section 5 of the 1992 amendments.

FDA has further clarified terms contained in the definition of an

``MDR reportable event'' throughout this document. These include:

``caused or contributed,'' as defined in Sec. 803.3(d) and discussed in

section IV.B., comment 11 of this document; ``information that

reasonably suggests that a device has or may have caused or contributed

to a death or serious injury'' as defined in Sec. 803.20(c) and

discussed in section IV. B., comment 11 of this document;

``malfunction'' as defined in Sec. 803.3(m) and discussed in section

IV.B., comment 12 of this document; ``become aware'' as defined in

Sec. 803.3(c) and discussed in sections IV.A., comments 2 and 6, and

IV.D., comment 27 of this document; and ``serious injury,'' as defined

in Sec. 803.3(aa) and discussed in section IV.B., comment 21 of this

document. The terms ``necessitated medical or surgical intervention''

and ``permanent,'' which are now included in the definition of

``serious injury,'' are also clarified in this document. ``Necessitated

medical or surgical intervention'' is discussed in section IV.B.,

comment 16 of this document. FDA believes that these added definitions

and discussion of these terms this document provides adequate

clarification of the term ``MDR reportable event.''

15. A few comments stated that the definition of ``manufacturer

report number'' (Sec. 803.3(o)), should be changed to allow flexibility

and permit

[[Page 63586]]

manufacturers to use their own numbers.

The agency disagrees. A uniform numbering system is essential for

FDA evaluation of reports, recordkeeping, filing and analyses. Because

the manufacturer report number is based on the manufacturer

registration number and all manufacturing sites are required to have a

registration number, there is no additional burden on the manufacturer

to comply with this requirement. If the manufacturer reporting site

does not have a registration number, FDA will assign a temporary

registration until the site is officially registered.

16. Several comments stated that the definition of ``necessitated

immediate medical or surgical intervention'' (proposed Sec. 803.3(o)),

included as an element of the ``serious injury'' definition in

Sec. 803.3(aa), which is unclear, overly broad, and unduly burdensome.

Some of these comments suggested that the terms ``timely'' and

``intervention'' be further defined or a standard for ``immediate

intervention be set (e.g., within 6 hours). Other comments suggested

that the event be reported only if significant intervention actually

occurred.

In light of the 1992 amendments, most of the comments relating to

the ``immediate medical or surgical intervention'' definition are no

longer relevant. Section 5(a)(2) of the 1992 amendments revised and

broadened the scope of reportable events that fall within the

definition of ``serious injury'' by deleting the immediacy requirement

from the definition. Under the 1992 amendments' revisions, FDA must

require that injuries be reported that necessitate medical or surgical

intervention to preclude permanent impairment of a body function or

permanent damage to a body structure, that have or may have been caused

by a device, regardless of the immediacy of the surgical or medical

intervention.

FDA agrees with comments suggesting that an event be reported if

significant intervention actually occurred. FDA believes, however, that

any intervention is per se ``significant'' if it is necessary to

preclude permanent impairment of a body function or permanent damage to

a body structure.

17. Many comments stated that the definition of ``patient of the

facility'' whose serious injuries and deaths user facilities must

report( Sec. 803.3(v)) is too broad. Several comments objected to

including individuals being diagnosed, treated, or receiving care

``under the auspices of'' the facility under this definition. Other

comments objected to including employees of the facility who suffer

death or serious injury from a device used at or by the facility as a

``patient of the facility.'' They further asserted that FDA does not

have clear jurisdiction over these types of employee events and that

MDR reports would duplicate reports required by other regulations

(e.g., Occupational Safety and Health Administration (OSHA)

regulations). A few comments suggested that the term ``patient'' be

further defined.

The agency agrees that including any individuals treated or

diagnosed ``under the auspices'' of a facility could be read very

broadly to include certain individuals that are not intended to be

covered by this regulation. Accordingly, FDA has revised this

definition to include only individuals that are ``being diagnosed or

treated and/or receiving medical care at or under the control or

authority of the facility.''

FDA does not agree, however, that employees of the facility who are

injured and/or receive medical care arising from a device-related event

at the facility should be excluded from the definition of ``patient of

the facility,'' and that information provided to other agencies for

work-related injuries is duplicative of information required in an MDR

report. FDA believes that facility employees who suffer injury or death

in a device-related event reasonably fall within the meaning of the

requirement under section 519(b)(1)(A) of the act to report such events

that involve a ``patient of the facility.'' To ensure the safety and

efficacy of devices, FDA needs information required in the MDR reports

for all device-related adverse events regardless of the individual's

employment relationship to the facility. MDR reports are required to

provide information that is specifically tailored to help FDA determine

the risks posed by a certain device and whether further action may be

necessary. Reports required by other agencies relating to work

injuries, such as OSHA, do not provide the MDR report information that

is necessary for FDA to make these determinations. Accordingly, there

is no unnecessary duplication involved in reporting.

18. A few comments stated that injuries must be reported because

they are ``permanent,'' (proposed Sec. 803.3(q)), should exclude

``trivial'' or ``cosmetic'' irreversible damage.

FDA agrees in part. To improve clarity, the agency has included the

definition of ``permanent'' with the ``serious injury'' definition

(Sec. 803.3(aa)). The agency has also modified the definition of

``serious injury'' to exclude trivial irreversible damage. While most

cosmetic damage will be trivial, not all cosmetic damage would be

considered trivial. Therefore, FDA is not excluding all cosmetic damage

from this definition.

19. A few comments recommended that the definition of

``probability, probable, or probably'' in the reporting standard be

clarified and suggested using a ``greater than 50 percent'' standard.

As discussed earlier in this document, the 1992 amendments deleted

the term ``probability'' from the reporting standard and revised the

standard for manufacturers and user facilities. Therefore, this

definition has been removed from the final rule.

20. A few comments stated that the definition of a ``remedial

action,'' (Sec. 803.3(y)), which is required to be reported under

Secs. 803.53(a) and 803.52(f)(7), is unclear. One comment suggested

that the definition be deleted; another suggested that it be removed

from the user reporting form.

The agency does not agree that this definition should be deleted.

The agency should be aware of remedial actions taken in response to

reportable events in order to thoroughly evaluate the event. However,

the definition has been reworded for clarity. Also, the request for

remedial action information has been removed from the user facility

section of the final reporting form (FDA Form 3500A) because user

facilities do not ordinarily undertake remedial actions. The revised

definition of ``remedial action'' appears in Sec. 803.3(y).

21. Several comments stated that the definition of a reportable

``serious injury or serious illness'' (Sec. 803.3(aa)) is overly broad

and needs to be better defined. Another comment suggested that these

terms be deleted from the manufacturer and distributor report forms

altogether. One comment suggested that ``temporary damage'' be excluded

from the definition.

The agency disagrees with comments that requirements to report

serious injuries or illnesses should be deleted from the manufacturer

and distributor reporting form. Section 519(a)(1)(a) of the act

requires manufacturers to report serious injuries. Nor does FDA agree

that the definitions of these terms are overly broad. The regulatory

definition in Sec. 803.3(aa) of the terms ``serious illness'' and

``serious injury'' are derived directly from the statutory definitions

provided in section 519(a)(2) and (b)(5)(B) of the act, as amended by

the 1992 amendments.

The SMDA added section 519(b)(5)(B) to require that user facilities

report ``serious illnesses'' as well as ``serious injuries.'' The 1992

amendments

[[Page 63587]]

amended section 519(a)(2) to require that manufacturers report only

``serious injuries.'' The statutory definitions of the terms ``serious

injury'' and ``serious illness,'' however, are identical. (See section

519(a)(2) and (b)(5)(B) of the act.) The legislative history of the

1992 amendments indicates that ``the term 'injury' probably covers any

illness that could be caused by a device * * *.''(138 Congressional

Record H 3884 (1992).)

In accordance with the statutory definition, FDA has defined

``serious injury'' to mean an injury or illness that is: (1) Life-

threatening; (2) results in permanent impairment of a body function or

permanent damage to body structure; or (3) necessitates medical or

surgical intervention to preclude permanent impairment of a body

function or permanent damage to a body structure.

As stated in response to comments described in section IV.B.,

comment 18 of this document, FDA has further clarified the definition

of serious injury by clarifying the term ``permanent'' within the

definition in Sec. 803.3(aa). Because section 519(a)(2) and (b)(5)(B),

as amended by the 1992 amendments, identically defines the terms

``serious injury'' and ``serious illness'' FDA has revised the

definition of the term ``serious injury'' to include ``serious

illness.''

FDA does not agree with the comment stating that temporary damage

should not fall within the definition of ``serious injury.'' Section

519(a)(2)(A) and (b)(5)(B) define serious injury to include any event

that is ``life-threatening.'' Because life-threatening events may

include temporary damage, FDA believes that life-threatening events

that may have been caused by a device must be reported, regardless of

whether the damage was ``temporary.''

22. One comment stated that the definition of ``user facility

report number'' (Sec. 803.3(dd)) needs to be more specific, especially

regarding leading zeroes in the number.

The agency agrees and has modified the definition for clarity. The

revised definition appears in Sec. 803.3(dd).

23. Several comments requested that the terms: ``become aware,''

``expected life,'' and ``shelf life'' be defined.

FDA agrees. These definitions have been included in the final rule

and appear in Sec. 803.3(c), (i), and (bb) respectively. For further

discussion of the term ``become aware,'' see sections IV.A., comments

2, 6, and IV.D., comment 27 of this document.

C. Section 803.9--Public Availability of Reports

24. Many comments expressed concern over confidentiality of the

reports.

The agency is aware of confidentiality concerns and will protect

the confidentiality of information to the fullest extent allowed under

the law. FDA is generally required, under the Freedom of Information

Act (FOIA) (5 U.S.C. 552), to make publicly available reports received

under this final rule. Public availability of such reports is governed

by FOIA and part 20 (21 CFR part 20). Before a report is made publicly

available, FDA, in accordance with FOIA and part 20 as promulgated in

1984, will delete from the report information whose disclosure would

constitute an invasion of personal privacy (see 5 U.S.C. 552(b)(6);

Sec. 20.63) or information that constitutes trade secret, confidential

commercial or financial information (see 5 U.S.C. 552(b)(4);

Sec. 20.61). Persons who are subjects of the reports, however, can

receive all information in the report concerning themselves, except for

trade secret, confidential commercial or financial information.

FDA has modified Sec. 803.9 in this final rule to clarify that the

identity of a third party who submits a voluntary adverse event report,

such as a physician or other health care professional, will be

protected. This revision does not add any new protection for voluntary

third-party reporters. It merely clarifies that the existing protection

afforded to voluntary reporters under Sec. 20.111 is applicable to MDR

reports.

Revised Sec. 803.9 incorporates the confidentiality provisions

relating to user facility reporting in section 519(b)(2) of the act, as

added by the SMDA. Specifically, Sec. 803.9(c) states that FDA may not

disclose the identity of a device user facility except in connection

with : (1) An action brought to enforce section 301(q) of the act (21

U.S.C. 331(q)), which includes the failure or refusal to furnish

material or information required by section 519 of the act; (2) a

communication to a manufacturer of a device which is the subject of a

report of a death, serious injury or other significant adverse device

experience required by a user facility under Sec. 803.30; (3) a

disclosure relating to a manufacturer or distributor report which is

required under section 519(a) of the act; and (4) a disclosure to

employees of the Department of Health and Human Services, to the

Department of Justice, or to duly authorized committees and

subcommittees of the Congress.

As stated above, Sec. 803.9, which is derived from the statutory

language in section 519(b)(2)(C) of the act, allows disclosure of the

user facility's identity when disclosure is required under provisions

requiring manufacturer and distributor reporting. The legislative

history of section 519(b)(2)(C) of the act states that this section is

not intended to affect public access to information contained in MDR

reports to FDA, and that the full requirements of reporting under

section 519(a) of the act (the manufacturer and distributor reporting

provisions), will apply. If a manufacturer chooses to forward a user

report to FDA, that will then constitute a report described in section

519(a) of the act, not a report described in section 519(b) of the act,

for purposes of public access to the contents of the report. (H. Rept.

101-808, 101st Cong., 2d sess., pp. 21-22). Accordingly, if information

in a required user facility report is submitted as part of a

distributor or manufacturer report, the information relating to the

identity of the user facility would be disclosable because the report

would be submitted under section 519(a) of the act. FDA notes that, in

accordance with part 20 and section 519(b) of the act, the agency will

not disclose the identity of the user facility physicians, persons

designated by the user facility to submit reports, or other user

facility employees, although the identity of the user facility may be

disclosed.

25. Many comments expressed concern that the regulation will

increase liability and that the availability of reports will lead to

civil litigation.

Although FDA is aware that litigants in civil suits may attempt to

use information in adverse event reports as evidence in product

liability suits, FDA does not have any information as to whether the

information from reports will actually lead to the initiation or

increase of civil litigation. Section 519 of the act requires user

facilities and manufacturers to submit reports of adverse events. While

these reports may have some effect on a reporter's liability, these

regulations are required to implement statutory requirements. They are

also necessary to make FDA aware of unsafe devices and better enable

the agency to take appropriate action to safeguard the public health.

With respect to user facilities, section 519(b)(3) of the act provides

some protection against liability in that it prohibits the

admissibility of device user facility adverse event reports into

evidence for civil actions involving private parties, except where the

party making the report had knowledge that information in the report is

false.

[[Page 63588]]

With respect to manufacturers and distributors, FDA has attempted

to provide protection from liability by clearly stating in Sec. 803.16

of this final rule, and including a statement on FDA Form 3500A, that

the submission of a report does not constitute an admission that the

user facility, manufacturer/distributor, product, or medical personnel

caused or contributed to the event. Moreover, in the Federal Register

of April 3, 1995 (60 FR 16962), FDA issued a final rule that became

effective on July 3, 1995, that protects the identity of voluntary

reporters by preempting State laws or other requirements requiring or

permitting disclosure.

26. Comments objected to providing FDA with proprietary

information.

FDA may require the submission of certain proprietary information

because it is necessary to fully evaluate the adverse event.

Proprietary information will be kept confidential in accordance with

Sec. 803.9, which prohibits public disclosure of trade secret or

confidential commercial information, and in accordance with the FOIA

and FDA regulations in 21 CFR part 20.

D. Reports by Device User Facilities (Part 803, Subpart C)

27. Several comments stated that 10 days is too short a time period

for user facilities to report adverse events properly. One comment

suggested that the 10-day ``clock'' for reporting should commence when

the facility completes its investigation and determines that an event

is reportable.

FDA cannot agree because the 10-day time period is the maximum time

allowed by the statute. (See section 519(b)(1)(A) of the act.) However,

this comment raises the issue of when the reporting ``clock'' starts.

In the preamble to the November 1991 tentative final rule, FDA proposed

to consider a user facility to have ``become aware'' of reportable

events only when it has sufficient information to make a determination

that a report is required, and that this commences the 10-day reporting

period. (See the notice of availability of the MEDWATCH adverse event

reporting form (FDA Form 3500A) in the Federal Register of June 3, 1993

(58 FR 31596.))

FDA has reevaluated the issue of when a user facility should be

considered to ``become aware'' of information that triggers the

reporting requirements and has determined that user facilities should

be considered to have ``become aware'' of information that triggers

reporting requirements when they first receive a report. The agency

does not believe that information-gathering required of user facilities

is sufficiently burdensome or time consuming to justify triggering the

10-day timeframe any time after they receive a report of an adverse

event. A user facility, unlike a manufacturer, is not required to

provide any information that is not in its possession. For further

discussion on when user facilities are considered to have ``become

aware'' of an event, see section IV.A, comment 2 of this document.

28. Several comments suggested that the user/operator error

reporting requirement be eliminated.

As stated in section IV.A., comment 3 of this document, the

language of the SMDA as amended by the 1992 amendments requires

reporting in all instances where the facility becomes aware of

information that reasonably suggests that a device has or may have

caused or contributed to certain device-related adverse events. FDA

needs to be aware of events that are related to user error any time

such error may have caused or contributed to a reportable event. By

receiving information on device user problems, FDA can determine

whether additional measures are necessary to resolve such problems, for

example, relabeling or a redesign of the device.

29. One comment suggested that all reports be sent only to FDA.

FDA does not agree. This regulation merely implements section

519(b) of the act, which requires user facilities to submit deaths to

FDA and the manufacturer, and serious injuries to the manufacturer or

FDA, if the identity of the manufacturer is unknown.

30. Some comments suggested that an anonymous reporting path be

provided for reporting directly to FDA.

FDA disagrees. It is important that both FDA and the manufacturer

know the identity of the user facility in case followup information is

needed. As discussed in section IV.C., comment 24 of this document, the

act does provide some protection of the identity of user facilities.

31. Several comments requested clarification of the terms ``adverse

events,'' ``formally affiliated,'' and ``user error.''

Adverse events are those events that may be related to an FDA-

regulated product and which have a negative or harmful effect on the

user or recipient of the product's use. The only adverse events

required to be reported under this regulation, however, are ``MDR

reportable events'' as defined in Sec. 803.3(q) of the final rule.

The term ``formally affiliated'' means individuals who are employed

by a user facility or medical personnel who have admitting, practicing,

or equivalent privileges at a user facility. Reporting requirements for

user facilities are triggered when medical personnel who are employed

by or otherwise ``formally affiliated'' with the facility, receive

information or become aware of information that reasonably suggests a

reportable event has occurred.

The term ``user error'' means any error made by the person using

the device. A user error may be the sole cause or merely contribute to

a reportable adverse event.

32. One comment suggested that FDA provide user facilities with

manufacturer and agency contacts. Another comment suggested that a

hotline be established for reporting.

It would be very difficult for FDA to establish and maintain up-to-

date manufacturer ``contact'' lists for device user facilities. The

agency, however, will consider publicizing a list of firm contact names

and telephone numbers. Although there is no requirement for telephone

reporting in this regulation, emergency situations can be handled in

accordance with Sec. 803.12(c) of this final rule.

33. One comment asked how foreign user facilities will be affected

by these provisions.

Only those user facilities located outside the United States which

are operated by the U.S. Government are required to report under this

regulation.

34. Comments suggested that the requirements for semiannual reports

be deleted because they are redundant. Other comments suggested that no

semiannual report be required if no reports had been submitted during

that period.

Semiannual reports are required by section 519(b)(1)(C) of the act

and therefore the requirement cannot be deleted. Under Sec. 803.33(c),

the user facility is not required to submit a semiannual report if no

reportable events occurred during the reporting period.

E. Reports by Manufacturers (Part 803, Subpart E)

35. One comment suggested that manufacturer reporting of ``planned

remedial actions'' be deleted. Another comment stated that remedial

action often occurs after the reporting deadline, and therefore cannot

be included in the report.

Remedial actions taken after a reporting deadline can be submitted

to the agency via a supplemental report. The individual adverse event

reports required under the final rule, with the exception of

circumstances requiring 5-day reports, do not require information

[[Page 63589]]

concerning ``planned remedial action'' because supplemental reports and

reports of Removals and Corrections will provide the agency with the

same information. Remedial actions that are necessary to prevent an

unreasonable risk to the public health should be reported as 5-day

reports under to Sec. 803.53.

36. Several comments requested that manufacturers be exempt from

the requirement of submitting supplemental reports because they are

vague and burdensome.

FDA does not agree. The supplemental report does not impose any

significant additional burden under Sec. 803.56 because it requires

information that a manufacturer was required to submit on its initial

report, but did not do so because such information was unknown or

unavailable at the time of the report. This information may include,

for example, the results of a firm's investigations that may not have

been completed at the time of the initial report, or any other required

information that the manufacturer becomes aware of after filing a

report. The information required is not vague and is clearly specified

in Secs. 803.52 and 803.56. Both initial and supplemental reports are

to be submitted on FDA Form 3500A or electronic equivalent.

Under Sec. 803.15, FDA may also require supplemental information

(termed ``request for additional information'' in the final rule) in

addition to that required on other reports specified in this part. FDA

believes these reports are not unduly burdensome given that they will

be required only in instances when the agency determines that the

protection of the public health requires such information. In such

cases, FDA will specify the type of information needed.

37. One comment stated that the quality of information will

decrease if manufacturers are denied access to products.

FDA agrees that manufacturers should evaluate a device problem if

they have access to the device. FDA has no authority to require that a

device be returned to the manufacturer, but the agency encourages

device users, when possible, to permit access or return the device to

the manufacturer for evaluation.

38. One comment suggested that manufacturer reports should be sent

to user facilities, as well as to FDA.

FDA does not agree. FDA believes that user facilities do not have

the appropriate resources or personnel to properly evaluate the public

health significance of manufacturers' reports. FDA is the proper entity

to evaluate MDR information to determine whether further action,

including notification to user facilities or others of device risks, is

appropriate.

39. A few comments suggested that the 1984 requirements for

manufacturer reporting should be retained to avoid possible confusion

caused by the creation of a new standard. Other comments called for the

elimination of the monthly reporting requirement.

As discussed earlier in the preamble, subsequent to the issuance of

the November 1991 tentative final rule, the 1992 amendments modified

the language for reporting standards that apply to user facilities,

manufacturers, and importers. The language used in the November 1991

tentative final rule no longer reflected the statutory language, as

modified. In this final regulation, FDA has revised the reporting

standard to reflect the statutory language added by the 1992

amendments. This statutory reporting standard is substantially similar

to the manufacturer reporting standard in the 1984 regulations.

Although the final regulation retains the reporting standard

language from the 1984 regulation referenced above, it incorporates

many changes from that regulation that are intended to enhance the

quality of the reports received and increase the efficiency of FDA's

report processing. FDA believes the benefits of changes implemented by

the new regulation far outweigh the limited costs for manufacturers to

familiarize themselves with the new requirements.

Under the final rule, manufacturers have 30 days after they become

aware of an MDR event (with the exception of 5-day reports required by

Sec. 803.53) to report the event to FDA. FDA, however, has eliminated

the portions of monthly reporting requirements, as proposed, that would

have required manufacturers to submit, in addition to individual

adverse event report information, an evaluation of adverse events

consisting of the results of a statistically-based trend analyses

conducted by the manufacturer, a discussion of the underlying

methodologies used, a description of any unusual or unexpected events,

and a description of remedial action taken.

As proposed, the greatest benefit of the evaluation portions of the

monthly report would have been the overview of adverse experience

trends it would provide. However, FDA has reevaluated the benefits of

these monthly reports, and determined that the agency would incur the

costs of data entry regardless of the industry's analysis, and that a

computer program for the analysis of the data may be used at a

relatively low cost to the agency. Furthermore, the agency anticipates

that internal trending analysis will be conducted as part of a

manufacturer's CGMP. Any remedial actions presenting an unreasonable

risk of substantial harm that are undertaken based upon internal trend

analyses are reportable in a 5-day report. Other essential information

under the proposed monthly report will also be made available to the

agency under the CGMP regulations, and would be made available to FDA

under the proposed reports of removals and corrections regulation.

The final regulation will also allow FDA to receive information

about reports sooner than the monthly reports as previously proposed.

The proposed regulation allowed the manufacturer up to 2 months from

the date of an adverse event to submit the monthly report. For example,

under the proposed regulation, information received by the manufacturer

on January 1 would have been due in a monthly report in March. Under

the final regulation, the manufacturer will submit all reports of

adverse events within 30 days of the event. Accordingly, under the

final rule, information about a reportable event the manufacturer

received on January 1, would have to be reported within 30 days.

FDA believes that the timeframes under the final regulation allow

sufficient time for completing individual reports because the

manufacturer would no longer be required to compile the trend analysis

and other evaluations as previously proposed for the monthly reports.

FDA also believes that the monthly reporting of individual adverse

events in the final rule will achieve FDA's goal of obtaining better

quality initial reports from manufacturers by allowing more time to

complete the reports than allowed under the 1984 regulation.

Nonetheless, the public health will benefit under the final rule

because FDA will receive reports of individual events sooner than under

the proposed rule.

40. One comment objected to the use of identification (ID) numbers

on the reporting form, claiming they are unnecessary.

The agency disagrees. Report ID numbers are essential to FDA's

ability to efficiently audit, process, analyze and evaluate MDR data.

One of the major deficiencies of the current system is its inability to

consistently identify similar devices and other data elements that

facilitate the comparison of adverse events. The use of device ID

numbers (Secs. 803.32(c)(6) and 803.52(c)(6)), user facility and

manufacturer report numbers (Secs. 803.3(dd) and (o), respectively)),

and event codes

[[Page 63590]]

(discussed in section IV.F., comment 52 of this document) will

facilitate information access and retrieval, and increase the agency's

ability to evaluate the information.

41. Comments stated that the requirement for firms to compare

events associated with the use of their devices, in order to perform

trending studies, should be removed.

The agency agrees in part and has deleted MDR trending reporting

requirements, as discussed in section IV.E, comment 39 of this

document. Under the prior reporting regulation, FDA has faced

difficulties in making an effective determination of the significance

of many device failures, because the reports did not include the total

number of similar devices in current use or similar failures. Such

information, which is required in baseline reports, provides the agency

with information regarding the rate of adverse events. An understanding

of device failure rates is essential for the agency to determine the

level of risk involved, and the appropriate regulatory or other public

health response.

42. One comment suggested that instead of the manufacturer

indicating to whom the information was reported in the monthly

reporting form, it is more important to indicate by whom it was

reported.

The agency agrees in part. As noted above, the monthly report

requirement, as proposed, has been eliminated; however, information

about the initial reporter is required on the individual adverse event

MEDWATCH form (FDA Form 3500A or an FDA approved electronic

equivalent).

43. One comment objected to the requirement to report problems

found in the scientific literature. Another comment objected to

reporting anything except problems found in the scientific literature

or from research.

Any information which reasonably suggests that a reportable event

occurred is important to evaluate the risks of a device, regardless of

the source. Although reports in the scientific literature or research

are usually not proximate in time to actual events, the information

often represents the results of cumulative observations and experience,

and provides important information to FDA about device safety and

effectiveness.

44. One comment stated that the manufacturer reporting requirements

are inappropriate for device sales made directly to the patient.

The agency disagrees. The act does not provide any restrictions or

limitations with respect to how the device was marketed. FDA would lose

a valuable source of information if manufacturers of devices sold

directly to patients, such as many apnea monitors or home use glucose

monitors, were excluded from this requirement. All information

concerning device-related deaths, serious injuries or other reportable

events is equally important, regardless of how the device is marketed.

45. One comment stated that there is no relationship between

devices shipped by the manufacturer and those on the market, as the

devices may have been altered; therefore, the manufacturer should not

be responsible for reporting events involving such devices.

The agency disagrees. Devices in commercial distribution are

presumed to be the same devices shipped by the manufacturer. If a

manufacturer receives information about an MDR event involving a device

that has been altered, the information must nevertheless be forwarded

to FDA with an explanation that the device has been altered.

46. One comment suggested that a U.S.-designated agent should be

responsible for reporting on behalf of foreign manufacturers.

FDA's November 1991 tentative final rule proposed that U.S.-

designated agents should be required to report for foreign

manufacturers. This requirement has been adopted in Sec. 803.58.

47. One comment suggested that the manufacturer should disclose the

results of event evaluations to distributors of the device.

FDA does not agree. Disclosure of evaluations would be burdensome

and may result in release of information that is protected under other

laws and regulations. FDA will inform the public, including

distributors, of steps necessary to protect the public health if the

agency determines such steps are necessary.

F. User Facility and Manufacturer Reporting Forms for Individual

Adverse Events (Secs. 803.32 and 803.52)

48. Several comments asserted that this section is costly,

complicated, overly broad, unacceptably burdensome and not consistent

with the SMDA as it requires the reporting of information not required

or supported by the SMDA.

The agency disagrees. As stated earlier in the preamble, FDA has

adopted the use of a single reporting form for most FDA-regulated

products, in order to facilitate the cost-efficient submission of

information required by or consistent with the provisions of the SMDA.

The agency agrees that the data elements could be simplified and has

modified the form after consideration of comments to the February 1993

notice submitted by medical device trade associations and other

regulated or affected entities. FDA anticipates that the consolidated

form will facilitate the submission, and improve the quality, of

adverse event reports. During the initial period of its use, FDA will

continue to closely monitor comments and suggestions received from

interested parties regarding the reporting form, and will consider

additional modifications to further improve the form as the need

arises.

49. One comment stated that it will be difficult to find

manufacturer reporting forms. Another comment stated that the report

form, distributed as a draft to certain interested parties, is not

compatible with the use of a word processor.

The MEDWATCH forms (FDA Forms 3500 and 3500A) are already in wide

distribution and were published in the Federal Register on June 3,

1993. Information about the MEDWATCH form, and how to obtain it, is

provided Secs. 803.10 and 803.11.

Although a word processor would be able to fill the fields on FDA

Form 3500A with great difficulty, the agency has made provisions for

the submission of reports on alternative (electronic) media which would

obviate the need for printing the form from a word processor.

50. Several comments were concerned with the adversarial and

litigation issues which may be raised by reporting on the forms. In

this regard, a few comments suggested deleting all items that require

speculation and judgment in reporting, removing the signature block, or

adding a disclaimer to the form.

As stated in section IV.C., comment 25 of this document, although

FDA is aware that these reports may have some effect on liability, the

required information is necessary to implement the agency's statutory

responsibilities. Under the statute, user facilities and manufacturers

must report adverse events when a device ``may'' have caused or

contributed to the event. Accordingly, FDA does not have the discretion

to require reporting only when a definitive causal relationship is

established. Furthermore, adoption of such a standard would preclude

FDA from receiving information that would help the agency assess the

risks associated with devices.

FDA has removed the signature block on the form. FDA has provided a

disclaimer statement on the reporting form, as discussed in section

IV.C., comment 25 of this document.

51. Some comments suggested that the evaluation of events or

reports be

[[Page 63591]]

left to FDA, the manufacturer or another third party. Other comments

suggested that the manufacturer should not be required to verify data

or provide data about which it has no knowledge. Other comments

suggested that user facilities do not have the appropriate expertise to

analyze events or make determinations concerning the reportability of

events.

FDA agrees that user facilities should not be required to conduct

in-depth analyses of events and has deleted certain requirements

regarding information relating to evaluation and testing. User

facilities serve principally as conduits of information and thus are

required only to fill out information that is known to them. However,

the statute and regulations still require user facilities to make an

initial determination as to whether an event should be reported under

the regulation's criteria. Accordingly, FDA has retained elements that

relate to this determination. In Sec. 803.30, FDA explains user

facilities' obligations to obtain information about adverse events.

FDA believes that the manufacturer who is responsible for placing a

device into interstate commerce is the appropriate entity to initially

investigate and evaluate whether, and why, the device may have caused

or contributed to a reportable event or malfunctioned and that such

malfunction is a reportable event. In order for FDA to determine

whether the risk posed by a device necessitates action to protect the

public health, the manufacturer is also required to verify data and

provide missing information after investigating the event. If after an

investigation the information cannot be determined, a manufacturer must

explain in the MDR report why the information cannot be obtained.

The agency agrees that an analysis of reports for patterns and

trends may be more appropriately conducted by the manufacturer or FDA.

FDA will conduct statistical analyses of report information submitted.

The agency expects that manufacturers will conduct trend analyses as

part of their CGMP.

52. Several comments suggested that numerical event and evaluation

codes should not be used on the adverse event reporting form. Other

comments stated that the codes lacked accuracy or were insufficient.

The agency disagrees. It is the manufacturer's responsibility to

evaluate reports to determine causation. It is reasonable that an

evaluation will result in the assignment or identification of failure

modes and that these can be communicated to FDA in the form of a

structured vocabulary or ``coded'' data. In developing these codes, the

agency has used the experience gained from reviewing nearly 400,000

reports submitted since 1984. The use of these codes is essential to

the rapid evaluation of device risks and processing of reports by

computer. Regardless of whether the codes are specific enough to

describe a particular event, the event must be fully described in the

narrative section of the reporting form.

The list of codes for use with the final form (FDA Form 3500A or

FDA approved electronic equivalent) has been expanded for completeness

and modified to improve accuracy. The agency will continue to improve

the accuracy of its codes as needed.

53. Various comments suggested that the following elements be

removed from the form: Degree of certainty, labelled usage, result of

analysis, list of other devices, purchase date, service and maintenance

items, event description, and medical status of the patient.

FDA has deleted requirements for user facilities and manufacturers

to report service and maintenance information and to state the degree

of certainty concerning whether the device caused or contributed to an

adverse event. FDA believes the burden of requiring this information

would usually outweigh the benefit of assessing the cause of an adverse

event. FDA, however, has retained the requirements for manufacturers to

report use indications specified in the labeling and device analyses

because this information is valuable in determining causation of the

event. FDA has deleted the requirements to report these elements for

user facilities because the agency believes the manufacturer is the

most appropriate source for this information. All user facilities and

manufacturers will still be required to provide information regarding

concomitant product use, age of the device, event description and

certain patient information. FDA believes this information is important

to assess adverse events and should be available to user facilities as

well as manufacturers.

G. Manufacturer Annual Certification Report (Sec. 803.57)

54. A few comments stated that this section is redundant, overly

broad and burdensome, exceeds the scope of the SMDA and should be

deleted. Another comment suggested that certification be limited to

events involving class III devices.

The agency cannot agree. Section 519(d) of the act states that each

manufacturer required to make reports under section 519(a) of the act

must submit annual statements certifying the number of reports filed or

that no reports were filed during the previous 12-month period. The

provisions of this regulation pertaining to the statutory certification

requirement merely explain what information should be contained in the

submission. Furthermore, FDA does not agree that certification should

be limited to reports about adverse events involving class III devices.

Any device, regardless of its classification, can pose serious risks

that need to be reported to FDA.

55. Some comments suggested that the certification be limited to

the number of reports actually filed, and that liability should attach

only in instances of known reporting violations.

The agency disagrees. The purpose of this provision is to ensure

reporter compliance with MDR requirements by certifying that all

reportable events have been submitted. Such purpose would be thwarted

and the certification requirement rendered meaningless if it were

limited to simply certifying the number of reports submitted instead of

all reportable events known to the certifying entity. The legislative

history of section 519(d) of the act references a U.S. General

Accounting Office recommendation that the certification state that the

reporter ``filed a specific number of reports * * * and that the firm

received or became aware of information concerning only these events.''

(H. Rept. 808, 101st Cong., 2d sess. 23 (1990)).

Accordingly, consistent with Congress' intent, FDA is requiring

certification that all known reportable events were reported. This

requirement does not impose liability for adverse events that are

unknown to the reporter because the reporting requirements are

triggered only when the reporting entity ``becomes aware'' of a

reportable event.

56. Several comments stated that the purpose of certification

should be to verify reports, not to certify with absoluteness;

therefore the standard should be changed to ``reasonably certain'' and

a disclaimer should be added.

The agency disagrees. Section 519(d) of the act specifically states

that firms shall certify, not verify their reports. As discussed in the

previous paragraph, the purpose of this provision is to ensure that the

reporter complies with the law by certifying that it has submitted all

the reports it was required to submit. This purpose would not be

accomplished by verifying the report.

57. One comment asked for clarification about who is required to

certify. Another comment suggested that

[[Page 63592]]

the signature block be for the certifier and contractor as well.

The agency agrees with the need for clarification regarding who

must certify and has incorporated language in the final rule to address

this suggestion. Under the final rule, the president, chief executive

officer, executive officer, U.S.-designated agent of a foreign

manufacturer or other official most directly responsible for the firm's

operations shall certify reports submitted under section 519 of the

act.

58. Two comments requested that decentralized certification be

allowed for multisite firms. Another comment suggested that centralized

reports be used in this situation.

Manufacturers have the option of certifying centrally or on a

decentralized basis. Firms deciding to certify centrally must identify

the sites covered by the certificate by name and registration number or

FDA-assigned identification number.

H. Additional Requirements (Sec. 803.15)

59. A few comments asserted that these provisions are vague and

inappropriate in the absence of a device failure complaint.

The agency disagrees. This provision refers to submission of

additional information after an adverse event report has been filed.

Accordingly, FDA would not be requesting information in the absence of

a device failure or complaint.

60. A few comments objected to the idea of giving FDA unlimited

access to data. One comment wanted to restrict FDA's right to copy data

and another wanted an appeal process.

FDA does not agree with comments proposing to restrict or limit the

agency's access to additional information about adverse events. Under

section 704(e) of the act, every person who is required to maintain

records under section 519 of the act and every person who is in charge

or custody of such records must permit FDA at all reasonable times to

have access to and to copy and verify such records. Failure to provide

such information may be a violation of section 301 of the act and may

subject a person to civil or criminal penalties. Section 704(e) of the

act does not limit in any way the types of device records maintained

under section 519 of the act that FDA may inspect.

FDA does not agree that the agency should be required to provide an

appeal process with respect to requests for additional information. As

described above, FDA has statutory authority to require additional

information concerning adverse events. Moreover, such information needs

to be provided as quickly as possible to enable FDA to take appropriate

action.

61. Several comments suggested the regulation be modified to remove

the requirement that each reportable event be investigated because in

some instances an investigation is unnecessary.

The agency disagrees. All reportable events must be investigated by

the manufacturer. The scope of an investigation may vary according to

the circumstances; however, an investigation must be able to adequately

assess the cause of the event. Sections 820.162 and 820.198 of FDA's

CGMP regulations require manufacturers to review, evaluate and

investigate any complaint involving the failure of a device to meet its

performance specifications or involving injury, death, or any hazard to

safety. FDA considers any event that must be reported under this part

to be a death, injury, or hazard to safety.

I. Exemptions, Variances, and Alternative Reporting Requirements

(Sec. 803.19)

62. One comment asked that alternative reporting requirements under

the current MDR system be incorporated into this regulation. One

comment stated that the criteria for alternative reporting should be

clarified.

FDA has incorporated the alternative reporting options from the MDR

regulation issued in 1984 and expanded the options available in this

regulation. Under the final regulation, FDA may grant a written

exemption, variance, or alternative to some or all of the requirements

when it determines compliance with all MDR requirements is not

necessary to protect the public health. Examples of situations include:

(1) Devices for which FDA is already aware of a type of malfunction and

appropriate action has been taken to protect the public health, such as

a recall, removal, or other correction; (2) adverse events that are

known and well documented, are occurring at a normal rate, and do not

justify the initiation of remedial action; and (3) device events

occurring on an infrequent basis or where a longer period for

investigation or followup is appropriate and necessary.

In these cases, FDA may impose conditions on its approval of an

exemption, variance, or alternative reporting mechanism, including the

requirement to report on a less frequent basis than otherwise required

or to provide summary data rather than individual reports. The final

regulation, upon its effective date, will supersede all previously

granted exemptions and variances from the 1984 reporting requirements.

The agency intends to review all current exemptions and variances and

notify relevant parties about the status of their exemptions and

variances and the additional steps that may be necessary to conform to

the new requirements effected by this regulation.

63. A few comments stated the criteria for exemption are unclear,

especially with respect to investigational device exemptions, and thus

create a loophole.

The criteria for exemptions (Sec. 803.19) are based upon

interpretations of the act as to the types of entities Congress

intended should be subject to reporting. FDA believes these exemptions

are reasonably clear. The exemptions specifically granted under this

final regulation are the same as those in the MDR regulation issued in

1984. Devices subject to investigational device exemptions are subject

to reporting under the regulations governing that process (parts 812

and 813). The exception to this are devices with investigational device

exemptions that are approved for export. These devices are considered

to be in commercial distribution and, therefore, subject to MDR.

J. Where To Submit a Report (Sec. 803.12)

64. There were only two comments on this section. One suggested

that ``MDR'' be added to the mailing address. The other recommended the

use of electronic reporting.

The agency agrees with these comments. ``MDR'' has been added to

the mailing address. In addition, the agency, with prior approval, will

accept required reports submitted electronically or on reporting media

such as magnetic disc or tape in accordance with Sec. 803.14(a). The

agency is in the process of developing standards, guidelines, or

procedures for the format to be used with electronic reports. Once

available, any electronic reporting system meeting such criteria will

be deemed to have prior FDA approval.

K. Written MDR Procedures (Sec. 803.17)

65. A few comments requested additional guidance on written MDR

procedures.

FDA agrees and has developed guidance concerning MDR procedures.

Requests for this guidance should be directed to:

Division of Small Manufacturers Assistance (HFZ-220), Office of

Health and Industry Programs, Center for Devices and Radiological

Health, 1350 Piccard Dr., Rockville, MD 20850.

[[Page 63593]]

Copies can also be obtained from an electronic docket maintained by

the Division of Small Manufacturers Assistance. This system can also be

accessed by dialing: 1-800-252-1366 or 301-594-2741. Persons wishing to

obtain the guidance document via this system must have a video terminal

or a personal computer with communication software (VT emulation) and a

modem that can operate at a baud rate of 1200, 2400, 4800, or 9600.

Persons wishing to transfer files from the electronic docket must use

the KERMIT file transfer protocol.

66. One comment requested that the requirement for staff education

be deleted.

The agency agrees and, as stated previously in this preamble, has

removed this requirement from the final regulation.

67. One comment objected to the requirement for written procedures.

Another comment objected to FDA having access to the firm's procedures.

The agency disagrees. Written procedures are essential to the

development of a standard, institutional reporting program. FDA also

needs access to such procedures so it can conduct an adequate audit of

user facility and manufacturer compliance with MDR.

68. One comment requested clarification of the term ``information

that facilitates a submission'' for which documentation and

recordkeeping requirements were proposed.

``Information that facilitates the submission [of a semiannual

report]'' refers to any information that was evaluated for the purpose

of preparing a semiannual report or certification. The regulation has

been revised in Sec. 803.17 to clarify this point.

69. One comment stated that these provisions do not address the

penalties for failure to comply.

FDA intends to enforce this regulation and will take appropriate

action against any firm or facility that does not comply. Violations

may result in criminal prosecutions and/or civil remedies such as

seizure, injunction, recall, and civil penalties. FDA's enforcement

mechanisms and penalties for noncompliance are detailed in the preamble

to the November 1991 tentative final rule (56 FR 60024 at 60029 through

60030).

L. Files (Sec. 803.18)

70. Several comments complained that these requirements are overly

broad, burdensome, and beyond the scope of the SMDA.

FDA does not agree. Sections 519 and 701 of the act provide FDA the

authority to require user facilities and manufacturers to maintain

records to ensure that devices are not adulterated or misbranded. The

file requirements are necessary to enable FDA to: (1) Further

investigate potentially adulterated or misbranded devices to determine

the cause of adverse events; (2) verify information received; and (3)

ensure compliance with the regulations. These filing requirements will

also enable the reporting entity to more readily identify causes of

problems associated with devices so they can take appropriate actions.

71. Several comments expressed concern about public access and a

loss of confidentiality stating that these will lead to increased

lawsuits and, therefore, decreased reporting. Some comments suggested

that only events reportable to FDA be kept in FDA accessible files.

Others suggested that confidential materials and irrelevant data be

excluded from the files.

FDA has addressed issues related to confidentiality of reports it

receives in section IV.C., comment 24 of this document. As stated

therein, certain statutory and regulatory protections exist that

prevent release of confidential information. FDA does not agree that

only events that are ultimately determined to be reportable should be

kept in MDR files. FDA must be able to audit files containing events

that were determined not reportable to ensure such determinations were

correct.

72. A few comments objected to FDA prescribing the method of record

retention, preferring the use of individual systems.

The agency disagrees. Effective and uniform regulatory enforcement

is better assured by a standardized method of record retention. The

agency believes that the method of record retention prescribed in this

regulation does not impose an undue burden on the entities required to

maintain such records.

73. One comment suggested that separate files be kept for devices

and patients.

FDA does not object to a reporting entity maintaining separate

files for devices and patients provided that all required information

is contained in the MDR files.

74. A few comments stated that a user facility should be required

to keep files for a maximum of 2 years, rather than the expected life

of the product, because some devices may have unusually long life

expectancies.

The agency agrees and has modified this section accordingly. It

should be noted that device manufacturers, however, are still required

to retain their records for 2 years or a period of time equivalent to

the expected life of the device, whichever is greater.

M. Who Must Register and Submit a Device List (Section 807.20)

75. One comment suggested that foreign manufacturers designate a

U.S. agent to fulfill the registration and certification requirements.

Another comment suggested that foreign manufacturers be permitted to

register.

Under Sec. 807.40 (21 CFR 807.40), foreign manufacturers are

required to designate a U.S. agent to serve as an official

correspondent, as well as to register and list their medical devices

distributed in the United States, submit premarket notifications and

ensure compliance with the MDR reporting requirements. In

Sec. 807.40(a), FDA has changed the time allowed for foreign

manufacturers to inform the agency of their designated U.S. agents, or

a change in such agents, from 30 days to 5 days. FDA believes this is

sufficient time to comply with this requirement.

76. Under Sec. 807.20 (21 CFR 807.20), an owner or operator is

required to register its ``name, places of business, and all

establishments.'' Under this regulation, FDA has required the

registration of all locations that fit within the definition of

``establishment,'' which is defined under Sec. 807.3(a) (21 CFR

807.3(a)) as a location where devices are ``manufactured, assembled, or

otherwise processed.'' Although FDA has authority under Sec. 807.20 to

require the registration of ``places of business'' that are not

``establishments'' under initial registration and listing regulation

that were issued in 1977, the agency previously has declined to

exercise this authority.

Under this regulation, FDA will use registration numbers in its

data bases to process all manufacturer adverse event reports. Thus FDA

must receive reports that originate from locations that may not be

``establishments'' and, therefore, have previously not had registration

numbers. Accordingly, FDA is notifying manufacturers that upon the

effective date of this final regulation, the agency will exercise its

authority under Sec. 807.20, and require all locations that are MDR

reporting sites to register because they are ``places of business''

under Sec. 807.20, regardless of whether they fit under the definition

of ``establishment.''

V. Environmental Impact

The agency has determined under 21 CFR 25.24(a)(8) that this action

is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore,

[[Page 63594]]

neither an environmental assessment nor an environmental impact

statement is required.

VI. Intergovernmental Partnership

The agency has analyzed this rulemaking in accordance with the

principles and criteria set forth in the Unfunded Mandate Reform Act

(Pub. L. 104-4) and Executive Order 12875. Executive Order 12875 states

that no agency or executive department shall promulgate any regulation

that is not required by statute and that creates a mandate upon a

State, local, or tribal government unless the Federal government

supplies funds necessary to comply with the mandate, or the agency

provides the Office of Management and Budget (OMB) a description of the

agency's consultations with affected State, local, and tribal

governments, the nature of their concerns, any written communications

submitted to the agency by such units of government, and the agency's

position supporting the need to issue the regulation containing the

mandate. Executive Order 12875 does not apply to this final rule

because the regulatory requirements that are applicable to government

facilities are required by the provisions of the SMDA, as amended by

the 1992 amendments. Moreover, many of the comments the agency received

in response to the November 26, 1991, tentative final rule were from

Federal, State, or local government facilities or from organizations

representing these facilities. The agency believes this final rule is

responsive to those comments.

The agency has also examined the consistency of this final rule

with the Unfunded Mandate Reform Act. The Unfunded Mandate Reform Act

requires (in section 202) that agencies prepare an assessment of

anticipated costs and benefits before proposing any rule that may

result in an annual expenditure by State, local, and tribal

governments, in the aggregate, or by the private sector, of $100

million (adjusted annually for inflation). The Unfunded Mandate Reform

Act does not apply to this final rule because it will not result in an

annual expenditure by State, local, and tribal governments, in the

aggregate, or by the private sector of $100 million.

VII. Analysis of Impacts

FDA has examined the impact of the final rule under Executive Order

12866 and the Regulatory Flexibility Act (Pub. L. 96-354). Executive

Order 12866 directs agencies to assess all costs and benefits of

available regulatory alternatives and, when regulation is necessary, to

select regulatory approaches that maximize net benefits (including

potential economic, environmental, public health and safety, and other

advantages; distributive impacts; and equity). The agency believes that

this final rule is consistent with the principles set out in the

Executive Order. In addition, the final rule is not a significant

regulatory action as defined by the Executive Order.

Many comments stated that the provisions of the rule, as proposed,

are overly burdensome, that the costs outweigh the benefits, and that

the economic impact was underestimated and misleading. Several comments

stated that the provisions constitute too great a burden for FDA, as

well as for user facilities, distributors, and manufacturers.

The agency does not agree. For the reasons stated in the preamble,

including section IV.A., comment 1 of this document, FDA believes this

regulation carefully balances the interests of public health with

industry requirements. The agency also does not agree that the economic

impact assessment was misleading. The cost projections contained in the

proposed rule were based upon the information available to the agency

at the time.

The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. The agency certifies that the final rule will not

have a significant economic impact on a substantial number of small

entities.

The full economic impact assessment is on file at the Dockets

Management Branch (address above). This rule is designed to: (1)

Implement provisions of the SMDA regarding user facility reporting to

FDA of deaths and serious injuries and illnesses related to medical

devices and (2) amend the MDR regulations that require manufacturers to

report deaths, serious injuries and malfunctions related to medical

devices to FDA.

A. Benefits

The legislative history of the SMDA documents reports that device

problems that occur in hospitals are rarely reported, despite full

scale implementation of the current medical device reporting

regulation. A 1986 Government Accounting Office report showed that less

than 1 percent of device problems occurring in hospitals were reported

directly to FDA. As a result, neither patients nor medical providers

would have access to relevant safety information. This final rule

requires user facilities to report device-related deaths and serious

injuries promptly, and thus it expands the information base of FDA and

the manufacturer for early detection of problems associated with

medical devices. In addition to manufacturers, those required to report

to FDA include device distributors, hospitals, nursing homes,

ambulatory surgical facilities, and outpatient treatment and diagnostic

facilities. As a result of this rule, FDA, patients, and medical

providers will have access to relevant safety information not

previously available. MDR reports alert FDA to life-threatening and

other serious problems with medical devices that are on the market, and

FDA then can address these problems through the appropriate mechanisms.

Further, when the final rule is in place, FDA will begin to receive

denominator, or baseline data, such as the number of a particular

device manufactured, distributed, and in use in the previous year. This

information will enable FDA to better perform trend analyses and

determine the significance of a report or group of reports.

Unfortunately, there are insufficient data available to quantify

the benefits of the rule. The primary benefit of this rule is that it

provides an early warning of device problems which is then evaluated

together with other information and, if appropriate, followed by a

corrective action such as the issuance of an FDA Safety Alert, recall,

or other action. The agency believes the actions taken as a result of

the information provided by MDR reports will provide benefits such as

injuries prevented, lives saved, avoidance of hospitalization and

outpatient treatment costs, and other possible benefits. Any

quantification of benefits would require an estimation of both the

number and seriousness of adverse events prevented by actions taken as

the result of the evaluation of MDR reports. Thus the agency does not

believe benefits can be quantified with any reliable accuracy.

B. Nature of the Economic Impact

This regulation will require certain device user facilities to

develop, maintain, and implement procedures for reporting deaths and

serious injuries related to medical devices. Some current MDR

requirements for manufacturers are being eliminated or reduced, but

manufacturers will now be required to develop and maintain written MDR

procedures and implement new reporting requirements, including the

submission of baseline reports and annual updates and annual

certification. In addition, foreign manufacturers will be required to

designate an agent in the United States that will be responsible

[[Page 63595]]

for submitting required documents for complying with the MDR reporting

requirements and for related documentation.

C. Impact Assessment

Based on the cost analysis, the economic impact on manufacturers,

U.S. agents for foreign manufacturers, and users of medical devices

will not exceed the $100 million threshold established under Executive

Order 12866. Annualized one-time costs of about $9.1 million will be

incurred by industry for establishing and/or documenting procedures for

data collection and reporting. In addition, the annual cost of user

reporting is estimated to be $31.7 million, for a total annualized

industry cost of $40.8 million.

An estimated 51,000 additional death and injury reports are

expected as a result of adverse incidents that must be reported under

this rule. This is in line with the Congressional Budget Office

estimate of 40,000 reports. These incidents generate investigation,

data analyses and summaries, and additional reporting requirements.

Based on the above estimates, this translates to an average cost per

adverse report of $799.

1. User Facility Costs

Table 1 summarizes the total incremental initial and recurring

costs of the reporting requirements for user facilities. These

estimates are based on cost data from the Center for Devices and

Radiological Health's draft report to Congress, entitled ``The

Evaluation of Medical Device User Facility Reporting Requirements'',

1994. Components of one-time costs include developing procedures and

modifying forms for reporting and training personnel. The most

significant one-time costs are $3.0 million for developing procedures

and $2.6 million for ``other'' startup costs. The total annualized one-

time cost to user facilities is estimated to be $8.9 million.

Table 1.--Total Costs to User Facilities by Type of Facility

[millions of dollars]

----------------------------------------------------------------------------------------------------------------

Number of One-time

Facility type facilities cost Annualized Annual Total

------------------------------------------------------------------------------\1\-------------------------------

Hospitals.................................... 6,738 7.9 1.9 7.0 8.9

Nursing homes................................ 25,648 12.7 3.1 5.3 8.4

Ambulatory surgical.......................... 1,300 0.7 0.2 0.7 0.9

Outpatient diagnostic........................ 7,578 3.3 0.8 0.7 1.5

Outpatient treatment......................... 4,041 2.5 0.6 1.4 2.0

Emergency medical service.................... 15,600 9.5 2.3 4.1 6.4

------------------------------------------------------------------

Total.................................. 60,905 36.6 8.9 19.3 28.2

----------------------------------------------------------------------------------------------------------------

\1\ Annualized over 5 years at a discount rate of 7 percent. (Numbers may not add due to rounding.)

Annual costs include investigation of the event, reporting the

event, preparing semiannual reports, and related computer, and other

costs. The total annual cost to user facilities is $19.3 million.

Hospitals and nursing homes incur about two- thirds of this cost at

$7.0 million and $5.3 million, respectively. Major components of annual

cost include $5.4 million to investigate and to prepare the initial

reports. Semiannual reports are required only if a facility has a

reportable event, and are estimated to cost $59,000. The most

significant costs are for computer and other costs at $14.8 million.

The total first-year costs to user facilities is $28.2 million.

2. Manufacturer and U.S. Agent for Foreign Manufacturer Costs

Manufacturers are currently required under the current good

manufacturing practices regulation to investigate complaints and

analyze device failures. Manufacturers will now be required to document

and maintain their MDR related procedures. The vast majority of

manufacturers already have such written procedures in place.

Incremental one-time costs for documenting these procedures will be

$105 thousand. Foreign manufacturers will incur additional one-time

costs of $662 thousand to select an agent and notify FDA. Annualized at

7 percent over 5 years, this translates to $187 thousand per year.

Manufacturers must also comply with the new reporting requirements.

Table 2 presents the expected annual cost of reporting by type of

facility and type of report. The major components of annual cost

include the followup and reporting of additional adverse medical device

events and the submission of baseline reports. MDR followup on user and

distributor reports and completion of information on Form 3500A is

expected to cost manufacturers $11.1 million annually for the estimated

51,000 reports from user facilities and distributors. The cost of 8,000

new baseline reports and 12,000 updates will be $598 thousand.

Table 2.--Annual Cost of Reporting

----------------------------------------------------------------------------------------------------------------

Cost Number of Total cost

Type of facility Type of report (dollars) reports ($000)

----------------------------------------------------------------------------------------------------------------

All manufacturers......................... Followup MDR's from user/ 217.60 51,000 11,098

distributor facilities.

Baseline report.............. 54.40 8,000 435

Baseline update.............. 13.60 12,000 163

Five-day report.............. 233.60 100 23

Annual certification......... 26.00 12,145 316

Foreign only.............................. Fees for MDR reporting....... ........... ........... 134

Fees for 510(k) filing....... 110.08 510 56

--------------------------------------

(All manufacturers-Total ).......... ............................. ........... ........... 12,225

======================================

U.S. agents for foreign manufacturers..... Register and list............ 16.64 4,812 80

[[Page 63596]]

Notify and document MDR's.... 7.80 5,750 45

--------------------------------------

(U.S. agents for foreign ............................. ........... ........... 125

manufacturers-Total).

======================================

Total............................... ............................. ........... ........... 12,350

----------------------------------------------------------------------------------------------------------------

In addition, domestic manufacturers and U.S. agents for foreign

manufacturers will be required to certify annually the number of

reportable events that have occurred. This is a formality in terms of

data collection and reporting and is expected to cost $316 thousand.

Foreign manufacturers will incur a fee of $190 thousand for reporting

services conducted by their U.S. agents. Annual costs to U.S. agents

are $125 thousand for registering and listing their foreign

manufacturers establishments and products and for complying with

reporting requirements. Previously, foreign manufacturers were required

to submit premarket notifications or have their initial distributor in

the United States do so. Now, U.S. agents will be required to submit

premarket notifications for foreign manufacturers. This represents a

transfer of existing requirements and therefore, no increase in cost.

3. Total Cost to Industry

Table 3 presents a summary of the total annual costs to industry.

Costs are $28.2 million for user facilities, $12.4 million for

manufacturers, and $125 thousand for U.S. agents for foreign

manufacturers, for a total annual cost to industry of $40.8 million.

Table 3.--Total Annualized Cost to Industry

[in millions of dollars]

------------------------------------------------------------------------

One-time

Industry \1\ Annual Total

------------------------------------------------------------------------

User Facilities........................... 8.93 19.31 28.24

Manufacturers............................. 0.19 12.22 12.41

U.S. agents for foreign manufactuers...... ........ 0.13 0.13

-----------------------------

Total............................... 9.12 31.66 40.77

------------------------------------------------------------------------

\1\ Annualized over 5 years at a discount rate of 7 percent. (Numbers

may not add due to rounding.)

4. Small Business Impacts

There is little likelihood that there will be a significant impact

on small facilities. The one-time start-up costs range from $437 to

$1,629 for user facilities, depending on facility type. Annualized at 7

percent for 5 years, these costs range from $107 to $397 for user

facilities. In addition, estimates of the annual number of additional

medical device events attributable to this regulation are about 51,000.

Because there are nearly 61,000 user facilities, this averages out to

about .8 serious events per facility attributable to the user reporting

rule at an annual cost of $400 per event.

Similarly, small businesses in the medical device manufacturing

industry will not be significantly affected, although the industry has

a substantial number of small facilities, with about 65 percent of the

establishments having fewer than 50 employees. No more than 22 percent

of the anticipated $12 million annual impact of these regulations on

manufacturers would be attributable to small establishments, or about

$2.7 million per year. Because there are about 7,300 small medical

device establishments (including foreign manufacturers), the average

impact on one small establishment should be less than $338 annually.

Assuming that all of the approximately 4,800 U.S. agents are small, on

average, the $125 thousand impact on any one establishment would be $26

annually.

VIII. Paperwork Reduction Act of 1995

This final rule contains information collections which are subject

to review by OMB under the Paperwork Reduction Act of 1995 (Pub. L.

104-13). The title, description, and respondent description of the

information collections are shown below and an estimate of the annual

recordkeeping and periodic reporting burden. Included in the estimate

is the time for reviewing instructions, searching existing data

sources, gathering and maintaining the data needed, and completing and

reviewing the collection of information.

Title: Reporting and recordkeeping requirements for user facilities

and manufacturers of medical devices under the Safe Medical Devices Act

of 1990 (SMDA) and the Medical Device Amendments of 1992 (1992

Amendments)(General requirements).

Description: This regulation implements provisions of the SMDA and

the 1992 amendments regarding user facility reporting of deaths and

serious injuries related to medical devices. This regulation also

amends regulations regarding device manufacturer reporting of deaths,

serious injuries, and certain malfunctions related to medical devices.

The purpose of these changes is to improve the protection of the public

health while also reducing the regulatory burden on reporting entities.

Description of Respondents: Businesses or other for profit

organizations, nonprofit organizations, Federal, State, and local

governments.

Table 4.--Estimated Annual Burden for Reporting

----------------------------------------------------------------------------------------------------------------

Number of

Number of responses Total Hours per

CFR section respondents per annual response Total hours

respondent responses

----------------------------------------------------------------------------------------------------------------

803.19......................................... 100 1.0 100 3.0 300

[[Page 63597]]

803.30(a)...................................... 700 1.0 700 3.0 2,100

803.30(b)...................................... 20,000 1.5 30,000 3.0 90,000

803.33......................................... 2,000 1.0 2,000 1.0 2,000

803.50......................................... 1,250 40.0 50,000 0.5 25,000

803.53......................................... 100 1.0 100 0.5 50

803.55......................................... 1,000 20.0 20,000 \1\ 1.1 22,000

803.56......................................... 500 20.0 10,000 1.0 10,000

803.57......................................... 12,000 1.0 12,000 1.0 12,000

803.58......................................... 5,000 1.0 5,000 1.0 5,000

----------------------------------------------------------------

Total.................................... ........... ........... ........... ........... 168,450

----------------------------------------------------------------------------------------------------------------

\1\ Although an initial submission will take an estimated 2 hours to complete, the annual update will take only

.5 hours. The average hours per response is therefore 1.1, as reflected here.

Table 5.--Estimated Annual Burden for Recordkeeping

------------------------------------------------------------------------

Number of Hours per

CFR section recordkeepers recordkeeper Total hours

------------------------------------------------------------------------

803.18(c)..................... 36,639 0.25 9,160

803.18(e)..................... 625 16.00 10,000

-----------------------------------------

Total................... ............. ............ 19,160

------------------------------------------------------------------------

Although the November 26, 1991, tentative final rule provided a 60-

day comment period (extended to 90 days in the January 24, 1992,

Federal Register, 57 FR 2861), and this final rule is based on the

comments received, FDA Form 3419 (semiannual report), FDA Form 3417

(baseline report), and FDA Form 3381 (annual certification) have not

been previously available to OMB or the public for review. Therefore,

as required by section 3507(d) of the Paperwork Reduction Act of 1995,

FDA has submitted a copy of this final rule to OMB for its review of

these information collection requirements.

In addition, the agency solicits public comment on the information

collection requirements in order to: (1) Evaluate whether the proposed

collection of information is necessary for the proper performance of

the functions of the agency, including whether the information will

have practical utility; (2) evaluate the accuracy of the agency's

estimate of the burden of the proposed collection of information,

including the validity of the methodology and assumptions used; (3)

enhance the quality, utility, and clarity of the information to be

collected; and (4) minimize the burden of the collection of information

on those who are to respond, including through the use of appropriate

automated, electronic, mechanical, or other technological collection

techniques or other forms of information technology, e.g., permitting

electronic submission of responses.

Individuals and organizations may submit comments on the

information collection requirements by January 10, 1996, and should

direct them to FDA's Dockets Management Branch (address above) and to

the Office of Information and Regulatory Affairs, OMB, New Executive

Office Bldg., rm. 10235, 725 17th St. NW., Washington, DC 20503,

Attention: Desk Officer for FDA.

Persons are not required to respond to a collection of information

unless it displays a currently valid OMB control number. This final

rule contains information collection requirements which have been

approved under OMB no. 0910-0059 and which expires on March 31, 1996.

FDA will publish a notice in the Federal Register prior to the

effective date of this final rule of OMB's decision to approve, modify

or disapprove the information collection requirements.

List of Subjects

21 CFR Part 803

Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 807

Confidential business information, Medical devices, Reporting and

recordkeeping requirements.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

the authority delegated to the Commissioner of Food and Drugs, chapter

I of title 21 of the Code of Federal Regulations is amended as follows:

1. Part 803 is revised to read as follows:

PART 803--MEDICAL DEVICE REPORTING

Subpart A--General Provisions

Sec.

803.1 Scope.

803.3 Definitions.

803.9 Public availability of reports.

803.10 General description of reports required from user facilities

and manufacturers.

803.11 Obtaining the forms.

803.12 Where to submit reports.

803.13 English reporting requirement.

803.14 Electronic reporting.

803.15 Requests for additional information.

803.16 Disclaimers.

803.17 Written MDR procedures.

803.18 Files.

803.19 Exemptions, variances, and alternative reporting

requirements.

Subpart B--Generally Applicable Requirements for Individual Adverse

Event Reports

803.20 How to report.

803.21 Reporting codes.

803.22 When not to file.

[[Page 63598]]

Subpart C--User Facility Reporting Requirements

803.30 Individual adverse event reports; user facilities.

803.32 Individual adverse event report data elements.

803.33 Semiannual reports.

Subpart D--[Reserved]

Subpart E--Manufacturer Reporting Requirements

803.50 Individual adverse event reports; manufacturers.

803.52 Individual adverse event report data elements.

803.53 Five-day reports.

803.55 Baseline reports.

803.56 Supplemental reports.

803.57 Annual certification.

803.58 Foreign manufacturers.

Authority: Secs. 502, 510, 519, 520, 701, 704 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i, 360j, 371,

374).

Subpart A--General Provisions

Sec. 803.1 Scope.

(a) This part establishes requirements for medical device

reporting. Under this part, device user facilities and manufacturers

must report deaths and serious injuries to which a device has or may

have caused or contributed, and must establish and maintain adverse

event files. Manufacturers are also required to report certain device

malfunctions and submit an annual report to FDA certifying that the

correct number of medical device reports were filed during the previous

12-month period or, alternatively, that no reports were required during

that same time period. These reports will assist FDA in protecting the

public health by helping to ensure that devices are not adulterated or

misbranded and are safe and effective for their intended use.

(b) This part supplements and does not supersede other provisions

of this subchapter, including the provisions of part 820 of this

chapter.

(c) References in this part to regulatory sections of the Code of

Federal Regulations are to Chapter I of title 21, unless otherwise

noted.

Sec. 803.3 Definitions.

(a) Act means the Federal Food, Drug, and Cosmetic Act.

(b) Ambulatory surgical facility (ASF) means a distinct entity that

operates for the primary purpose of furnishing same day outpatient

surgical services to patients. An ASF may be either an independent

entity (i.e., not a part of a provider of services or any other

facility) or operated by another medical entity (e.g., under the common

ownership, licensure or control of an entity). An ASF is subject to

this regulation regardless of whether it is licensed by a Federal,

State, municipal, or local government or regardless of whether it is

accredited by a recognized accreditation organization. If an adverse

event meets the criteria for reporting, the ASF must report that event

regardless of the nature or location of the medical service provided by

the ASF.

(c) Become aware means that an employee of the entity required to

report has acquired information reasonably suggesting a reportable

adverse event has occurred. Device user facilities are considered to

have ``become aware'' when medical personnel, as defined in paragraph

(r) of this section, who are employed by or otherwise formally

affiliated with the facility, acquire such information about a

reportable event. Manufacturers are considered to have ``become aware''

of an event when:

(1) Any employee becomes aware of a reportable event that is

required to be reported within 30 days, or that is required to be

reported within 5 days pursuant to a written request from FDA under

803.53(b); and

(2) Any employee, who is a person with management or supervisory

responsibilities over persons with regulatory, scientific, or technical

responsibilities, or a person whose duties relate to the collection and

reporting of adverse events, becomes aware that a reportable MDR event

or events, from any information, including any trend analysis,

necessitate remedial action to prevent an unreasonable risk of

substantial harm to the public health.

(d) Caused or contributed means that a death or serious injury was

or may have been attributed to a medical device, or that a medical

device was or may have been a factor in a death or serious injury,

including events occurring as a result of:

(1) Failure;

(2) Malfunction;

(3) Improper or inadequate design;

(4) Manufacture;

(5) Labeling; or

(6) User error.

(e) (1) Device family means a group of one or more devices

manufactured by or for the same manufacturer and having the same:

(i) Basic design and performance characteristics related to device

safety and effectiveness,

(ii) Intended use and function, and

(iii) Device classification and product code.

(2) Devices that differ only in minor ways not related to safety or

effectiveness can be considered to be in the same device family.

Factors such as brand name and common name of the device and whether

the devices were introduced into commercial distribution under the same

510(k) or premarket approval application (PMA), may be considered in

grouping products into device families.

(f) Device user facility means a hospital, ambulatory surgical

facility, nursing home, outpatient diagnostic facility, or outpatient

treatment facility as defined in paragraphs (l), (b), (s), (t), and

(u), respectively, of this section, which is not a ``physician's

office,'' as defined in paragraph (w) of this section. School nurse

offices and employee health units are not device user facilities.

(g) [Reserved]

(h) [Reserved]

(i) Expected life of a device (required on the manufacturer's

baseline report) means the time that a device is expected to remain

functional after it is placed into use. Certain implanted devices have

specified ``end of life'' (EOL) dates. Other devices are not labeled as

to their respective EOL, but are expected to remain operational through

maintenance, repair, upgrades, etc., for an estimated period of time.

(j) FDA means the Food and Drug Administration.

(k) Five-day report means a medical device report that must be

submitted by a manufacturer to FDA pursuant to Sec. 803.53, on FDA Form

3500A or electronic equivalent as approved under Sec. 803.14, within 5

work days.

(l) Hospital means a distinct entity that operates for the primary

purpose of providing diagnostic, therapeutic (medical, occupational,

speech, physical, etc.), surgical and other patient services for

specific and general medical conditions. Hospitals include general,

chronic disease, rehabilitative, psychiatric, and other special-purpose

facilities. A hospital may be either independent (e.g., not a part of a

provider of services or any other facility) or may be operated by

another medical entity (e.g., under the common ownership, licensure or

control of another entity). A hospital is covered by this regulation

regardless of whether it is licensed by a Federal, State, municipal or

local government or whether it is accredited by a recognized

accreditation organization. If an adverse event meets the criteria for

reporting, the hospital must report that event regardless of the nature

or location of the medical service provided by the hospital.

(m) Malfunction means the failure of a device to meet its

performance specifications or otherwise perform as intended.

Performance specifications include all claims made in the labeling for

the device. The intended

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performance of a device refers to the intended use for which the device

is labeled or marketed, as defined in Sec. 801.4 of this chapter.

(n) Manufacturer means any person who manufactures, prepares,

propagates, compounds, assembles, or processes a device by chemical,

physical, biological, or other procedure. The term includes any person

who:

(1) Repackages or otherwise changes the container, wrapper or

labeling of a device in furtherance of the distribution of the device

from the original place of manufacture;

(2) Initiates specifications for devices that are manufactured by a

second party for subsequent distribution by the person initiating the

specifications;

(3) Manufactures components or accessories which are devices that

are ready to be used and are intended to be commercially distributed

and intended to be used as is, or are processed by a licensed

practitioner or other qualified person to meet the needs of a

particular patient; or

(4) Is the U.S. agent of a foreign manufacturer.

(o) Manufacturer report number means the number that uniquely

identifies each individual adverse event report submitted by a

manufacturer. This number consists of three parts as follows:

(1) The FDA registration number for the manufacturing site of the

reported device. (If the manufacturing site does not have a

registration number, FDA will assign a temporary number until the site

is officially registered. The manufacturer will be informed of the

temporary number.);

(2) The four-digit calendar year in which the report is submitted;

and

(3) The five-digit sequence number of the reports submitted during

the year, starting with 00001. (For example, the complete number will

appear 1234567-1995-00001.)

(p) MDR means medical device report.

(q) MDR reportable event (or reportable event) means:

(1) An event about which user facilities become aware of

information that reasonably suggests that a device has or may have

caused or contributed to a death or serious injury; or

(2) An event about which manufacturers have received or become

aware of information that reasonably suggests that one of their

marketed devices:

(i) May have caused or contributed to a death or serious injury; or

(ii) Has malfunctioned and that the device or a similar device

marketed by the manufacturer would be likely to cause or contribute to

a death or serious injury if the malfunction were to recur.

(r) Medical personnel, as used in this part, means an individual

who:

(1) Is licensed, registered, or certified by a State, territory, or

other governing body, to administer health care;

(2) Has received a diploma or a degree in a professional or

scientific discipline;

(3) Is an employee responsible for receiving medical complaints or

adverse event reports; or

(4) Is a supervisor of such persons.

(s)(1) Nursing home means an independent entity (i.e., not a part

of a provider of services or any other facility) or one operated by

another medical entity (e.g., under the common ownership, licensure, or

control of an entity) that operates for the primary purpose of

providing:

(i) Skilled nursing care and related services for persons who

require medical or nursing care;

(ii) Hospice care to the terminally ill; or

(iii) Services for the rehabilitation of the injured, disabled, or

sick.

(2) A nursing home is subject to this regulation regardless of

whether it is licensed by a Federal, State, municipal, or local

government or whether it is accredited by a recognized accreditation

organization. If an adverse event meets the criteria for reporting, the

nursing home must report that event regardless of the nature, or

location of the medical service provided by the nursing home.

(t)(1) Outpatient diagnostic facility means a distinct entity that:

(i) Operates for the primary purpose of conducting medical

diagnostic tests on patients;

(ii) Does not assume ongoing responsibility for patient care; and

(iii) Provides its services for use by other medical personnel.

(Examples include diagnostic radiography, mammography, ultrasonography,

electrocardiography, magnetic resonance imaging, computerized axial

tomography and in-vitro testing).

(2) An outpatient diagnostic facility may be either independent

(i.e., not a part of a provider of services or any other facility) or

operated by another medical entity (e.g., under the common ownership,

licensure, or control of an entity). An outpatient diagnostic facility

is covered by this regulation regardless of whether it is licensed by a

Federal, State, municipal, or local government or whether it is

accredited by a recognized accreditation organization. If an adverse

event meets the criteria for reporting, the outpatient diagnostic

facility must report that event regardless of the nature or location of

the medical service provided by the outpatient diagnostic facility.

(u) (1) Outpatient treatment facility means a distinct entity that

operates for the primary purpose of providing nonsurgical therapeutic

(medical, occupational, or physical) care on an outpatient basis or

home health care setting. Outpatient treatment facilities include

ambulance providers, rescue services, and home health care groups.

Examples of services provided by outpatient treatment facilities

include: Cardiac defibrillation, chemotherapy, radiotherapy, pain

control, dialysis, speech or physical therapy, and treatment for

substance abuse.

(2) An outpatient treatment facility may be either independent

(i.e., not a part of a provider of services or any other facility) or

operated by another medical entity (e.g., under the common ownership,

licensure, or control of an entity). An outpatient treatment facility

is covered by this regulation regardless of whether it is licensed by a

Federal, State, municipal, or local government or whether it is

accredited by a recognized accreditation organization. If an adverse

event meets the criteria for reporting, the outpatient treatment

facility must report that event regardless of the nature or location of

the medical service provided by the outpatient treatment facility.

(v) Patient of the facility means any individual who is being

diagnosed or treated and/or receiving medical care at or under the

control or authority of the facility. For the purposes of this part,

the definition encompasses employees of the facility or individuals

affiliated with the facility, who in the course of their duties suffer

a device-related death or serious injury that has or may have been

caused or contributed to by a device used at the facility.

(w) Physician's office means a facility that operates as the office

of a physician or other health care professional (e.g., dentist,

chiropractor, optometrist, nurse practitioner, school nurse offices,

school clinics, employee health clinics, or

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