Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting; Companion Document to Direct Final Rule

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 803 and 804

[Docket No. 98N-0170]

Medical Device Reporting: Manufacturer Reporting, Importer

Reporting, User Facility Reporting, and Distributor Reporting;

Companion Document to Direct Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

certain regulations governing reporting by manufacturers, importers,

distributors, and health care (user) facilities of adverse events

related to medical devices. This proposed rule is a companion document

to the direct final rule, published elsewhere in this issue of the

Federal Register. The amendments are intended to implement provisions

of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the

Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is

publishing this companion proposed rule under FDA's usual procedures

for notice and comment to provide a procedural framework to finalize

the rule in the event the agency receives a significant adverse comment

and withdraws the direct final rule.

DATES: Submit written comments on or before July 27, 1998. Submit

written comments on the information collection requirements on or

before July 13, 1998.

ADDRESSES: Submit written comments on the proposed rule to the Dockets

Management Branch (HFA-305), Food and Drug Administration, 12420

Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Patricia A. Spitzig, Center for

Devices and Radiological Health (HFZ-500), Food and Drug

Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-2812.

SUPPLEMENTARY INFORMATION: This proposed rule is a companion to the

direct final rule published in the final rules section of this issue of

the Federal Register. This companion proposed rule is substantively

identical to the direct final rule. This proposed rule will provide a

procedural framework to finalize the rule in the event the agency

receives a significant adverse comment and the direct final rule is

withdrawn. FDA is publishing the direct final rule

[[Page 26130]]

because the rule contains noncontroversial changes, and FDA anticipates

that it will receive no significant adverse comments. A detailed

discussion of this rule is set forth in the preamble of the direct

final rule. If no significant comment is received in response to the

direct final rule, no further action will be taken related to this

proposed rule. Instead, FDA will publish a confirmation notice within

30 days after the comment period ends confirming that the direct final

rule will go into effect on September 24, 1998. Additional information

about FDA's direct final rulemaking procedures is set forth in a

guidance published in the Federal Register of November 21, 1997 (62 FR

62466).

If FDA receives a significant adverse comment regarding this rule,

the agency will publish a document withdrawing the direct final rule

within 30 days after the comment period ends and will proceed to

respond to the comments under this rule using usual notice-and-comment

procedures. The comment period for this companion proposed rule runs

concurrently with the direct final rule's comment period. Any comments

received under this companion proposed rule will also be considered as

comments regarding the direct final rule. A significant adverse comment

is defined as a comment that explains why the rule would be

inappropriate, including challenges to the rule's underlying premise or

approach, or would be ineffective or unacceptable without a change. In

determining whether a significant adverse comment is sufficient to

terminate a direct final rulemaking, FDA will consider whether the

comment raises an issue serious enough to warrant a substantive

response in a notice-and-comment process. Comments that are frivolous,

insubstantial, or outside the scope of the rule will not be considered

adverse under this procedure. For example, a comment recommending a

rule change in addition to the rule will not be considered a

significant adverse comment, unless the comment states why the rule

would be ineffective without the additional change. In addition, if a

significant adverse comment applies to part of a rule and that part can

be severed from the remainder of the rule, FDA may adopt as final those

parts of the rule that are not the subject of a significant adverse

comment.

This action is part of FDA's continuing effort to achieve the

objectives of the President's ``Reinventing Government'' initiative,

and is intended to reduce the burden of unnecessary regulations on

medical devices without diminishing the protection of public health.

I. Background

Under the act and the Medical Device Amendments of 1976 (Pub. L.

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

regulations for manufacturers on September 14, 1984 (49 FR 36326). 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 Safe Medical Devices Act of 1990 (Pub. L.

101-629) that required medical device user facilities and distributors

to report certain device-related adverse events.

Distributor reporting requirements became effective on May 28,

1992, following the November 26, 1991, publication of those provisions

in a tentative final rule (56 FR 60024). 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 and were now codified in part 804 (21 CFR part 804).

On June 16, 1992, the President signed into law the Medical Device

Amendments of 1992 (the 1992 amendments) (Pub. L. 102-112) amending

certain provisions of section 519 of the act (21 U.S.C. 360i) relating

to reporting of adverse device events. Prior to the 1992 amendments,

distributors and manufacturers reported adverse events by using a

``reasonable probability'' standard. Importers may be manufacturers or

distributors, depending on their activities. Among other things, the

1992 amendments amended section 519 to change the reporting standard

for manufacturers and importers, however, the reporting standard for

distributors who are not importers remained the same.

On November 21, 1997, the President signed FDAMA into law. FDAMA

made several changes regarding the reporting of adverse events related

to devices, including the elimination of reporting requirements for

certain distributors, which became effective on February 19, 1998, that

are reflected in this proposed rule. However, section 422 of FDAMA

states that FDA's regulatory authority under the act, relating to

tobacco products, tobacco ingredients, and tobacco additives shall be

exercised under the act as in effect on the day before the date of

enactment of FDAMA. Because the authority relating to tobacco products

remains the same, the reporting requirements for manufacturers and

distributors (including distributors who are importers) of cigarettes

or smokeless tobacco remain unchanged.

Under part 897, the regulations pertaining to tobacco products, and

parts 803 and 804, the regulations pertaining to device adverse event

reporting, importers may be either manufacturers or distributors,

depending on their activities. Under parts 897, 803, and 804, importers

who repackage or relabel are manufacturers. Similarly, under those

sections, importers whose sole activity is distribution of devices are

defined as distributors.

As previously stated, the 1992 amendments created a bifurcated

reporting standard for distributors, depending on whether they are

domestic distributors or importers. When the agency asserted

jurisdiction over tobacco products and issued regulations under part

897, tobacco distributors also became subject to this bifurcated

reporting standard. Accordingly, the reporting standard applicable to

tobacco products distributors has depended on whether the distributor

is domestic or an importer. Consistent with section 422 of FDAMA, the

proposed rule states that tobacco distributors will continue to use the

appropriate reporting standard as described in Sec. 804.25.

Changes made by FDAMA relating to reporting requirements for all

medical devices other than tobacco products are as follows:

1. Section 213(a) of FDAMA revised section 519(a) of the act to

eliminate distributors as an entity required to report adverse device

events. Importers are still required to report under section 519(a) of

the act.

2. Section 213(a) also amended section 519(a) of the act to clarify

that existing requirements continue to apply for distributors to keep

records concerning adverse device events and to make them available to

FDA upon request.

3. Section 213(a)(2) revoked section 519(d) of the act, which

required manufacturers, importers, and distributors to submit to FDA an

annual certification concerning the number of reports filed under

section 519(a) in the preceding year. As a result, certification

requirements are eliminated.

4. Section 213(c)(1)(A) of FDAMA revised section 519(b)(1)(C) of

the act to require that device user facilities submit an annual rather

than a semiannual summary of their reports to FDA.

5. Section 213(c)(1)(B) of FDAMA eliminated section 519(b)(2)(C) of

the act. This section had required FDA to

[[Page 26131]]

disclose, upon request, the identity of a user facility making a report

under section 519(b), if the identity of the user facility was included

in a report submitted by a manufacturer, distributor, or importer. As a

result of this change by FDAMA, FDA may now disclose the identity of a

user facility only in connection with an action concerning a failure to

report or false or fraudulent reporting, in a communication to the

manufacturer of the device, or to the employees of the Department of

Health and Human Services, the Department of Justice, and duly

authorized committees and subcommittees of Congress.

To implement these provisions, FDA is issuing this proposed rule. A

summary of the rule is contained in the preamble to the direct final

rule published elsewhere in this issue of the Federal Register.

II. Environmental Impact

The agency has determined under 21 CFR 25.30(h) that this action is

of a type that does not individually or cumulatively have a significant

effect on the human environment. Therefore, neither an environmental

assessment nor an environmental impact statement is required.

III. Analysis of Impacts

FDA has examined the impact of the proposed rule under Executive

Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612) (as

amended by subtitle D of the Small Business Regulatory Fairness Act of

1996 (Pub. L. 104-121)), and the Unfunded Mandates Reform Act of 1995

(Pub. L. 104-4). 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 proposed rule is consistent with

the regulatory philosophy and principles identified in the Executive

Order. In addition, this proposed rule is not a significant regulatory

action as defined by the Executive Order and so is not subject to

review under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. The proposed rule would eliminate reporting by

distributors, other than distributors (including distributors who are

importers) of cigarettes or smokeless tobacco, continue reporting by

importers (including distributors who are importers), increase

protections from disclosure of the identity of device user facilities

that have submitted reports, reduce summary reporting by device user

facilities from semiannual to annual, eliminate annual certification

for manufacturers and distributors (including importers) of medical

devices other than cigarettes or smokeless tobacco, and make other

nonsubstantive changes. The agency certifies that this proposed rule

will not have a significant economic impact on a substantial number of

small entities. This proposed rule also does not trigger the

requirement for a written statement under section 202(a) of the

Unfunded Mandates Reform Act because it does not impose a mandate that

results in an expenditure of $100 million or more by State, local, or

tribal governments in the aggregate, or by the private sector, in any 1

year.

IV. Paperwork Reduction Act of 1995

This proposed rule contains information collection provisions that

are subject to review by the Office of Management and Budget (OMB)

under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The

title, description, and respondent description of the information

collection provisions are shown as follows with an estimate of the

annual reporting and recordkeeping burden. Included in the estimate is

the time for reviewing the instructions, searching existing data

sources, gathering and maintaining the data needed, and completing and

reviewing each collection of information. FDA invites comments on: (1)

Whether the proposed collection of information is necessary for the

proper performance of FDA's functions, including whether the

information will have practical utility; (2) the accuracy of FDA's

estimate of the burden of the proposed collection of information,

including the validity of the methodology and assumptions used; (3)

ways to enhance the quality, utility, and clarity of the information to

be collected; and (4) ways to minimize the burden of the collection of

information on respondents, including through the use of automated

collection techniques, when appropriate, and other forms of information

technology.

Title: Reporting and recordkeeping requirements for manufacturers,

importers, user facilities, and distributors of medical devices under

FDAMA.

Description: FDAMA contained provisions that affect medical device

reporting in a variety of ways. Section 213 of FDAMA modified the

summary reporting requirements for user facilities to require annual,

rather than semiannual, reporting, and increased confidentiality of

user facility identities. This section of FDAMA also eliminated the

reporting requirements for medical device distributors (but not for

importers), as well as the certification requirements for medical

device manufacturers and distributors. However, section 422 of FDAMA

states that FDA's regulatory authority under the act relating to

tobacco products, tobacco ingredients, and tobacco additives shall be

exercised under the act as in effect on the day before the date of

enactment of FDAMA. Under this rule of construction, the reporting and

certification requirements for manufacturers and distributors

(including distributors who are importers) of cigarettes or smokeless

tobacco remain unchanged.

This proposed rule would amend FDA's regulations in 21 CFR Parts

803 and 804 to reflect the changes to medical device reporting made by

FDAMA.

This proposed rule would eliminate reporting by distributors other

than distributors of cigarettes or smokeless tobacco, continue

reporting by importers, increase the protection from disclosure of the

identity of device user facilities that have submitted reports, reduce

summary reporting by device user facilities from semiannual to annual,

eliminate annual certification for manufacturers and distributors

(including importers) of medical devices other than cigarettes or

smokeless tobacco, and make other nonsubstantive changes.

Description of Respondents: Businesses or other for profit

organizations.

FDA estimates the burden for this collection of information as

follows:

[[Page 26132]]

Table 1.--Estimated Annual Reporting Burden

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21 CFR No. of Responses per

Section No. of Respondents Respondent Total Annual Responses Hours per Response Total Hours

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803.19 150 1 150 3 450

803.33 1,800 1 1,800 1 1,800

803.40 195 1 195 3 585

803.56 750 20 15,000 1 15,000

803.57 31 1 31 1 31

804.25 10 1 10 1.5 15

804.30 1,365 1 1,365 1 1,365

804.32 5 1 5 1 5

804.33 0 0 0 1 0

Total .......................... .......................... .......................... .......................... 19,251

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Table 2.--Estimated Annual Recordkeeping Burden

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21 CFR Annual Frequency per

Section No. of Recordkeepers Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours

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803.17 2,000 1 2,000 2 4,000

803.18 39,764 1 39,764 1.5 59,646

804.34 1,365 1 1,365 1 1,365

804.35 1,365 1 1,365 1.5 2,047

Total .......................... .......................... .......................... .......................... 67,058

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Note: There are no operating and maintainance cost or capital costs associated with this collection of information.

The burdens under this proposed rule are explained as follows:

A. Reporting Requirements

Prior to the program change proposed in this rule, Sec. 803.19

allowed manufacturers or user facilities to request an exemption or

variance from the reporting requirements. The agency had estimated that

it would receive approximately 100 such requests annually. Distributors

(including importers) were able to request an exemption or variance

from the reporting requirements under Sec. 804.33. Under this proposed

rule, Sec. 803.19 would be modified to transfer the exemption

provisions for importers of medical devices other than cigarettes or

smokeless tobacco from Sec. 804.33 to Sec. 803.19. Furthermore,

distributors (who are not importers) of medical devices other than

cigarettes or smokeless tobacco would no longer be required to submit

MDR reports under this proposed rule. The estimated burden for

Sec. 803.19 is further adjusted to reflect the agency's actual

experience with this type of submission.

Prior to the program change proposed in this rule, Sec. 803.33

required medical device user facilities to submit summary reports

semiannually. Under this proposed rule, user facilities would be

required to submit summary reports annually, thereby significantly

decreasing the reporting burden on user facilities. The estimated

burden for this section is also adjusted to reflect the agency's actual

experience with this type of submission.

Under this proposed rule the reporting requirement for importers of

medical devices other than cigarettes or smokeless tobacco previously

codified under Sec. 804.25 would be transferred to new proposed

Sec. 803.40. The estimated burden for importer reporting is based upon

the agency's actual experience with this type of submission. The

reporting requirements for distributors (including distributors who are

importers) of cigarettes or smokeless tobacco would be retained in part

804.

Prior to the program change proposed in this rule, Sec. 803.56

required manufacturers to submit supplemental reports containing

information not known or not available at the time the initial report

was submitted. The agency had estimated that it would receive

approximately 500 such requests annually. Distributors (including

distributors who are importers) were required to submit supplemental

information under Sec. 804.32. Under this proposed rule, Sec. 803.56

would be modified to transfer the supplemental reporting requirements

for importers of medical devices other than cigarettes or smokeless

tobacco from Sec. 804.32. Furthermore, distributors (who are not

importers) of medical devices other than cigarettes or smokeless

tobacco would no longer be required to submit MDR reports (and thus

supplemental reports as well) under this proposed rule. The estimated

burden for Sec. 803.56 is further adjusted to reflect the agency's

actual experience with this type of submission. The agency also notes

that any additional information requested by the agency in accordance

with Sec. 803.15 is considered to be supplemental information for the

purpose of this information collection and is included in the burden

estimate for Sec. 803.56.

Prior to the program change proposed in this rule, Sec. 803.57

required medical device manufacturers to annually certify as to the

number of reports submitted during the previous year, or that no such

reports had been submitted. Distributors (including importers) were

required to certify under Sec. 804.30. Under this proposed rule,

Sec. 803.57 would be modified to require annual certification only for

manufacturers of cigarettes or smokeless tobacco. The certification

requirements for distributors (including distributors who are

importers) of cigarettes or smokeless tobacco would be retained in

Sec. 804.30.

Prior to the program change proposed in this rule, Sec. 804.25

required medical device distributors (including importers) to report

adverse device events. Under this proposed rule, distributors of

medical devices other than cigarettes or smokeless tobacco are no

longer required to submit MDR reports, and the reporting requirements

for importers of medical devices other than cigarettes or smokeless

tobacco would be transferred to part 803. Section 804.25 would require

distributors (including distributors who are importers) of cigarettes

or smokeless tobacco to submit MDR reports for adverse events related

to contamination of their products. The agency believes that there will

be a very small number of MDR reports related to contamination

[[Page 26133]]

of cigarettes or smokeless tobacco submitted in any given year.

Prior to the program change proposed in this rule, Sec. 804.30

required medical device distributors (including importers) to certify

as to the number of MDR reports submitted during the previous year, or

that no such reports were submitted. Under this rule, the certification

requirement has been removed for distributors (including distributors

who are importers) of medical devices other than cigarettes or

smokeless tobacco. Section 804.30 now would require distributors

(including distributors who are importers) of cigarettes or smokeless

tobacco to submit certifications of the number of MDR reports submitted

for adverse events related to contamination of their products. The

agency has identified 1,365 distributors of cigarettes or smokeless

tobacco, each of which would submit one certification annually.

Prior to the program change proposed in this rule, Sec. 804.32

required medical device distributors (including importers) to submit

supplemental information related to a previously submitted MDR report.

Under this proposed rule, distributors of medical devices other than

cigarettes or smokeless tobacco are no longer required to submit any

MDR reports, and the reporting requirements for importers of medical

devices other than cigarettes or smokeless tobacco would be transferred

to part 803. Section 804.32 would require distributors (including

distributors who are importers) of cigarettes or smokeless tobacco to

submit supplemental information related to a previously submitted MDR

report. Because the agency believes that there will be a very small

number of MDR reports related to contamination of cigarettes or

smokeless tobacco submitted in any given year, even fewer supplemental

submissions are anticipated. The agency also notes that any additional

information requested by the agency in accordance with section 804.31

is considered to be supplemental information for the purpose of this

information collection and is included in the burden estimate for

Sec. 804.32.

Prior to the program change proposed in this rule, Sec. 804.33

allowed medical device distributors (including importers) to request an

exemption or variance from the reporting requirements. Under this rule,

the exemption provisions for importers of medical devices other than

cigarettes or smokeless tobacco would be transferred to Sec. 803.19,

and distributors (who are not importers) of medical devices other than

cigarettes or smokeless tobacco are no longer required to submit any

MDR reports under this rule. Section 804.33 would allow distributors

(including distributors who are importers) of cigarettes or smokeless

tobacco to request an exemption or variance from the reporting

requirements. However, because distributors (including distributors who

are importers) of cigarettes or smokeless tobacco are required only to

submit reports of adverse events related to contamination of their

products, the agency does not anticipate any requests for exemptions or

variances from the reporting requirements.

B. Recordkeeping Requirements

Prior to the program change proposed in this rule, Sec. 803.17

required manufacturers and user facilities to establish written

procedures for employee education, complaint processing, and

documentation of information related to MDR's. Under this proposed

rule, the requirement for establishing written MDR procedures for

importers of medical devices other than cigarettes or smokeless tobacco

would be transferred to Sec. 803.17, and the requirements for

distributors (including importers) of medical devices other than

cigarettes of smokeless tobacco would be retained in Sec. 804.34. The

agency believes that the majority of manufacturers, user facilities,

and importers have already established written procedures to document

complaints and information related to MDR reporting as part of their

internal quality control system. The agency has estimated that no more

than 2,000 such entities would be required to establish new procedures,

or revise existing procedures, in order to comply with this provision.

For those entities, a one-time burden of 10 hours, annualized over a

period of 5 years, is estimated for establishing written MDR

procedures. The remainder of manufacturers, user facilities and

importers not required to revise their written procedures to comply

with this provision are excluded from the burden because the

recordkeeping activities needed to comply with this provision are

considered ``usual and customary'' under 5 CFR 1320.3(b)(2).

Prior to the program change proposed in this rule, Sec. 803.18

required manufacturers and user facilities to establish and maintain

MDR event files. Distributors (including importers) were required to

establish and maintain MDR event files under Sec. 804.35. Under this

proposed rule, Sec. 803.18 would be modified to transfer the

recordkeeping requirements for importers and other distributors of

medical devices other than cigarettes or smokeless tobacco from

Sec. 804.35. Recordkeeping requirements for distributors (including

distributors who are importers) of cigarettes or smokeless tobacco

would be retained in Sec. 804.35.

Prior to the program change proposed in this rule, Sec. 804.34

required distributors (including importers) of all medical devices to

establish written procedures for employee education, complaint

processing and documentation of information related to MDR reports.

Under this proposed rule, distributors of medical devices other than

cigarettes or smokeless tobacco would no longer be required to submit

MDR reports although distributors are required to establish device

complaint files in accordance with 21 CFR 820.198. Accordingly, they

would no longer be subject to the requirement to establish and maintain

written MDR procedures. Under the proposed rule, the requirement for

establishing written MDR procedures for importers of medical devices

other than cigarettes or smokeless tobacco would be transferred to

Sec. 803.17, and the requirements for distributors (including

distributors who are importers) of cigarettes or smokeless tobacco

would be retained in Sec. 804.34. The agency has estimated a one-time

burden of 10 hours, annualized over a period of 5 years, for

distributors (including distributors who are importers) of cigarettes

or smokeless tobacco to establish written MDR procedures under

Sec. 804.34.

Prior to the program change proposed in this rule, Sec. 804.35

required distributors (including importers) to establish and maintain

MDR event files. Under this proposed rule, the recordkeeping burdens

for distributors (including importers) of medical devices other than

cigarettes or smokeless tobacco would be transferred to Sec. 803.18.

Recordkeeping requirements for distributors (including distributors who

are importers) of cigarettes or smokeless tobacco would be retained in

Sec. 804.35.

For consistency with the direct final rule to which this proposed

rule is a companion, FDA is following the Paperwork Reduction Act

comment procedures for direct final rules in this proposed rule. As

provided in 5 CFR 1320.5(c)(1), collections of information in a direct

final rule are subject to the procedures set forth in 5 CFR 1320.10.

Interested persons and organizations may submit comments on the

information collection provisions of this proposed rule July 13, 1998

to the Dockets Management Branch (address above).

[[Page 26134]]

At the close of the 60 day comment period, FDA will review the

comments received, revise the information collection provisions as

necessary, and submit these provisions to OMB for review. FDA will

publish a notice in the Federal Register when the information

collection provisions are submitted to OMB, and an opportunity for

public comment to OMB will be provided at that time. Prior to the

effective date of the direct final rule, FDA will publish a notice in

the Federal Register of OMB's decision to approve, modify, or

disapprove the information collection provisions. An agency may not

conduct or sponsor, and a person is not required to respond to, a

collection of information unless it displays a currently valid OMB

control number.

V. Request for Comments

Interested persons may, on or before July 27, 1998, submit to the

Dockets Management Branch (address above) written comments regarding

this companion proposed rule. The comment period runs concurrently with

the comment period for the direct final rule. Two copies of any

comments are to be submitted, except that individuals may submit one

copy. Comments are to be identified with the docket number found in the

brackets in the heading of this document. Comments will be considered

to determine whether to amend or revoke this proposed rule. Received

comments may be seen in the office above between 9 a.m. and 4 p.m.,

Monday through Friday. All comments received will be considered as

comments regarding the direct final rule and this proposed rule. In the

event the direct final rule is withdrawn, all comments received

regarding the direct final rule and this companion proposed rule will

be considered comments on this proposed rule.

List of Subjects in 21 CFR Parts 803 and 804

Imports, Medical devices, Reporting and recordkeeping requirements.

Therefore, under the Federal Food, Drug, and Cosmetic Act, and

under authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR parts 803 and 804 be amended as follows:

PART 803--MEDICAL DEVICE REPORTING

1. The authority citation for 21 CFR part 803 continues to read as

follows:

Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

2. Section 803.1 is amended by revising paragraph (a) to read as

follows:

Sec. 803.1 Scope.

(a) This part establishes requirements for medical device

reporting. Under this part, device user facilities, importers, and

manufacturers, as defined in Sec. 803.3, must report deaths and serious

injuries to which a device has or may have caused or contributed, must

establish and maintain adverse event files, and must submit to FDA

specified followup and summary reports. Medical device distributors, as

defined in Sec. 803.3, are also required to maintain incident files.

Furthermore, manufacturers and importers are also required to report

certain device malfunctions. 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.

* * * * *

3. Section 803.3 is amended by redesignating paragraphs (m) through

(ee) as paragraphs (n) through (ff), respectively; by revising the last

sentence of the introductory text of paragraph (c), paragraph (c)(1),

and redesignated paragraphs (p), (p)(1), and (r)(2); and by adding

paragraphs (g) and (m) to read as follows:

Sec. 803.3 Definitions.

* * * * *

(c) * * * Manufacturers and importers 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 by an importer within 10 days, or by a

manufacturer within 30 days or within 5 days under a written request

from FDA under Sec. 803.53(b); and

* * * * *

(g) Distributor means, for the purposes of this part, any person

(other than the manufacturer or importer) who furthers the marketing of

a device from the original place of manufacture to the person who makes

final delivery or sale to the ultimate user, but who does not repackage

or otherwise change the container, wrapper or labeling of the device or

device package. One who repackages or otherwise changes the container,

wrapper, or labeling, is a manufacturer under Sec. 803.3(o). For the

purposes of this part, distributors do not include distributors of

cigarettes or smokeless tobacco.

* * * * *

(m) Importer means, for the purposes of this part, any person who

imports a device into the United States and who furthers the marketing

of a device from the original place of manufacture to the person who

makes final delivery or sale to the ultimate user, but who does not

repackage or otherwise change the container, wrapper, or labeling of

the device or device package. One who repackages or otherwise changes

the container, wrapper, or labeling, is a manufacturer under

Sec. 803.3(o). For the purposes of this part, importers do not include

importers of cigarettes or smokeless tobacco.

* * * * *

(p) Manufacturer or importer report number means the number that

uniquely identifies each individual adverse event report submitted by a

manufacturer or importer. This number consists of three parts as

follows:

(1) The FDA registration number for the manufacturing site of the

reported device, or for the importer. (If the manufacturing site or the

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

temporary number until the site is officially registered. The

manufacturer or importer will be informed of the temporary number.);

* * * * *

(r) * * *

(2) An event about which manufacturers or importers 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 or importer would be likely to cause a

death or serious injury if the malfunction were to recur.

* * * * *

Sec. 803.9 [Amended]

4. Section 803.9 Public availability of reports is amended by

adding ``or'' after the semicolon at the end of paragraph (c)(2), by

removing paragraph (c)(3), and by redesignating paragraph (c)(4) as

paragraph (c)(3).

5. Section 803.10 is amended by revising the heading and paragraphs

(a)(2) and (c)(5), and by adding paragraph (b) to read as follows:

Sec. 803.10 General description of reports required from user

facilities, importers, and manufacturers.

(a) * * *

(2) User facilities must submit annual reports as described in

Sec. 803.33.

(b) Importers must submit MDR reports of individual adverse events

within 10 working days after the importer becomes aware of an MDR

reportable event as described in Sec. 803.3. Importers must submit

reports of device-related deaths or serious injuries to FDA and the

manufacturer and reports of malfunctions to the manufacturer.

[[Page 26135]]

(c) * * *

(5) For manufacturers of cigarettes or smokeless tobacco, annual

certification to FDA of the number of MDR reports filed during the

preceding year as described in Sec. 803.57.

Sec. 803.11 [Amended]

6. Section 803.11 Obtaining the forms is amended in the first

sentence by adding the word

``, importers,'' after the phrase ``User facilities''.

7. Section 803.12 is amended by revising paragraph (b) to read as

follows:

Sec. 803.12 Where to submit reports.

* * * * *

(b) Each report and its envelope shall be specifically identified,

e.g., ``User Facility Report,'' ``Annual Report,'' ``Importer Report,''

``Manufacturer Report,'' ``5-Day Report,'' ``Baseline Report,'' etc.

Sec. 803.17 [Amended]

8. Section 803.17 Written MDR procedures is amended in the

introductory paragraph by adding the word ``, importers,'' after the

phrase ``User facilities''.

9. Section 803.18 is amended by revising the heading, the first

sentence of paragraphs (a) and (b)(1) introductory text, paragraphs

(b)(1)(ii) and (b)(2), and the second sentence of paragraph (c), and by

adding paragraph (d) to read as follows:

Sec. 803.18 Files and distributor records.

(a) User facilities, importers, and manufacturers shall establish

and maintain MDR event files. * * *

(b)(1) For purposes of this part, ``MDR event files'' are written

or electronic files maintained by user facilities, importers, and

manufacturers. * * *

(ii) Copies of all MDR forms, as required by this part, and other

information related to the event that was submitted to FDA and other

entities (e.g., an importer, distributor, or manufacturer).

(2) User facilities, importers, and manufacturers shall permit any

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

and to verify the records required by this part.

(c) * * * Manufacturers and importers shall retain an MDR event

file relating to an adverse event for a period of 2 years from the date

of the event or a period of time equivalent to the expected life of the

device, whichever is greater. * * *

(d)(1) A device distributor shall establish device complaint files

in accordance with Sec. 820.198 of this chapter and maintain an

incident record containing any information, including any written or

oral communication, that alleges deficiencies related to the identity,

quality, durability, reliability, safety, effectiveness, or performance

of a device. Device incident records shall be prominently identified as

such and shall be filed by device.

(2) A device distributor shall retain copies of the records

required to be maintained under this section for a period of 2 years

from the date of inclusion of the record in the file or for a period of

time equivalent to the design and expected life of the device,

whichever is greater, even if the distributor has ceased to distribute

the device that is the subject of the record.

(3) A device distributor shall maintain the device complaint files

established under this section at the distributor's principal business

establishment. A distributor that is also a manufacturer may maintain

the file at the same location as the manufacturer maintains its

complaint file under Secs. 820.180 and 820.198 of this chapter. A

device distributor shall permit any authorized FDA employee, during all

reasonable times, to have access to, and to copy and verify, the

records required by this part.

Sec. 803.19 [Amended]

10. Section 803.19 Exemptions, variances, and alternative reporting

requirements is amended by adding in paragraphs (b) and (c) the word

``, importers,'' before the phrase ``or user facility,'' and by adding

in paragraph (c) a comma after the word ``variance''.

11. Section 803.20 is amended by revising the last sentence of

introductory text of paragraph (a), paragraph (a)(1), and the first

sentence of paragraph (a)(2), and by adding paragraph (b)(2) to read as

follows:

Sec. 803.20 How to report.

(a) * * * The form has sections that must be completed by all

reporters and other sections that must be completed only by the user

facility, importer, or manufacturer.

(1) The front of FDA Form 3500A is to be filled out by all

reporters. The front of the form requests information regarding the

patient, the event, the device, and the ``initial reporter'' (i.e., the

first person or entity that submitted the information to the user

facility, manufacturer, or importer).

(2) The back part of the form contains sections to be completed by

user facilities, importers, and manufacturers. * * *

(b) * * *

(2) Importers are required to submit MDR reports to FDA and the

device manufacturer, except for malfunctions which are reported to the

manufacturer only:

(i) Within 10 working days of becoming aware of information that

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

to a death or serious injury.

(ii) Within 10 working days of receiving information that a device

marketed by the importer has malfunctioned and that such a device or a

similar device marketed by the importer would be likely to cause or

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

recur.

* * * * *

Sec. 803.22 [Amended]

12. Section 803.22 When not to file is amended by adding in

paragraphs (a) and (b)(1) the word ``, importer,'' after the word

``facility''.

Sec. 803.33 [Amended]

13. Section 803.33 Semiannual reports is amended by revising the

heading to read ``Annual reports''; in introductory text of paragraph

(a) by removing the phrase ``(for reports made July through December)

and by July 1 (for reports made January through June)''; in

introductory text of paragraph (a) and paragraphs (a)(5), (a)(7)

introductory text, and (c) by removing the word ``semiannual'' wherever

it appears and adding in its place the word ``annual''; in paragraph

(a)(2) by removing the phrase ``and period, e.g., January through June

or July through December''; and by adding in paragraph (a)(7)(vi) the

word ``importer,'' after the word ``distributor,''.

14. Subpart D, consisting of Secs. 803.40 and 803.43, is added to

read as follows:

Subpart D--Importer Reporting Requirements

Sec.

803.40 Individual adverse event reporting requirements; importers.

803.43 Individual adverse event report data elements.

Subpart D--Importer Reporting Requirements

Sec. 803.40 Individual adverse event reporting requirements;

importers.

(a) An importer shall submit to FDA a report, and a copy of such

report to the manufacturer, containing the information required by

Sec. 803.43 on FDA form 3500A as soon as practicable, but not later

than 10 working days after the importer receives or otherwise becomes

aware of information from any source, including user facilities,

individuals, or medical or scientific

[[Page 26136]]

literature, whether published or unpublished, that reasonably suggests

that one of its marketed devices may have caused or contributed to a

death or serious injury.

(b) An importer shall submit to the manufacturer a report

containing information required by Sec. 803.43 on FDA form 3500A, as

soon as practicable, but not later than 10 working days after the

importer receives or otherwise becomes aware of information from any

source, including user facilities, individuals, or through the

importer's own research, testing, evaluation, servicing, or maintenance

of one of its devices, that one of the devices marketed by the importer

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

the importer would be likely to cause or contribute to a death or

serious injury if the malfunction were to recur.

Sec. 803.43 Individual adverse event report data elements.

(a) Each importer that submits a report on an MDR reportable event

shall complete and submit the applicable portions of FDA form 3500A in

so far as the information is known or should be known to the importer,

and submit it to FDA, and to the manufacturer as required by

Sec. 803.40.

(b) Each importer shall submit the information requested on FDA

form 3500A, including:

(1) Identification of the source of the report.

(i) Type of source that reported the event to the importer (e.g.,

lay user owner, lay user lessee, hospital, nursing home, outpatient

diagnostic facility, outpatient treatment facility, ambulatory surgical

facility);

(ii) Importer report number;

(iii) Name, address, and telephone number of the source that

reported the event to the importer (e.g., distributor, user facility,

practitioner, etc.); and

(iv) Name of the manufacturer of the device.

(2) Date information.

(i) The date of the occurrence of the event;

(ii) The date the source that reported the event to the importer

became aware of the event;

(iii) The date the event was reported to the manufacturer and/or

FDA; and

(iv) The date of this report.

(3) The type of MDR reportable event (e.g., death, serious illness,

serious injury, or malfunction), and whether an imminent hazard was

involved;

(4) Patient information including age, sex, diagnosis, and medical

status immediately prior to the event and after the event;

(5) Device information including brand and labeled name, generic

name, model number or catalog number or other identifying numbers,

serial number or lot number, purchase date, expected shelf life/

expiration date (if applicable), whether the device was labeled for

single use, and date of implant (if applicable);

(6) Maintenance/service information data including the last date of

service performed on the device, where service was performed, whether

service documentation is available, and whether service was in

accordance with the service schedule;

(7) Whether the device is available for evaluation and, if not, the

disposition of the device;

(8) Description of the event, including:

(i) Who was operating or using the device when the event occurred;

(ii) Whether the device was being used as labeled or as otherwise

intended;

(iii) The location of the event;

(iv) Whether there was multi-patient involvement, and if so, how

many patients were involved;

(v) A list of any other devices whose performance may have

contributed to the event and their manufacturers, and the results of

any analysis or evaluation with respect to such device (or a statement

of why no analysis or evaluation was performed); and

(vi) A complete description of the event including, but not limited

to, what happened, how the device was involved, the nature of the

problem, patient followup/treatment required, and any environmental

conditions that may have influenced the event.

(9) The results of any analysis of the device and the event,

including:

(i) The method of the evaluation or an explanation of why no

evaluation was necessary or possible;

(ii) The results and conclusions of the evaluation;

(iii) The corrective actions taken; and

(iv) The degree of certainty concerning whether the device caused

or contributed to the reported event;

(10) The name, title, address, telephone number, and signature of

the person who prepared the report.

Sec. 803.56 [Amended]

15. Section 803.56 Supplemental reports is amended in the

introductory paragraph and in paragraphs (a) and (b) by adding the

words ``or importer'' after the word ``manufacturer''.

Sec. 803.57 [Amended]

16. Section 803.57 Annual certification is amended in paragraphs

(a) and (d) by removing the word ``manufacturers'' wherever it appears

and by adding in its place the phrase ``manufacturers of cigarettes or

smokeless tobacco'', and in paragraphs (b), (c)(1), and (d) by removing

the word ``manufacturer'' wherever it appears and adding in its place

the phrase ``manufacturer of cigarettes or smokeless tobacco''.

PART 804--MEDICAL DEVICE REPORTING FOR DISTRIBUTORS OF CIGARETTES

OR SMOKELESS TOBACCO

17. The authority citation for 21 CFR part 804 continues to read as

follows:

Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

18. Part 804 is amended by revising the heading to read as set

forth above.

19. Section 804.1 is amended by revising paragraph (a) to read as

follows:

Sec. 804.1 Scope.

(a) FDA is requiring distributors of cigarettes or smokeless

tobacco to report deaths, serious illnesses, and serious injuries that

are attributed to contamination of a cigarette or smokeless tobacco

product. Distributors of cigarettes or smokeless tobacco are also

required to submit a report to FDA annually certifying the number of

medical device reports filed during the preceding year, or that no

reports were filed. These reports enable FDA to protect the public

health by helping to ensure that these products are not adulterated or

misbranded and are otherwise safe and effective for their intended use.

In addition, distributors of cigarettes or smokeless tobacco are

required to establish and maintain complaint files or incident files as

described in Sec. 804.35, and to permit any authorized FDA employee at

all reasonable times to have access to, and to copy and verify, the

records contained in this file. This part supplements, and does not

supersede, other provisions of this subchapter, including the

provisions of part 820 of this chapter.

* * * * *

20. Section 804.3 is amended by revising paragraph (d), and in

paragraphs (m)(1) and (m)(2) by adding the phrase ``related to the

contamination of cigarettes or smokeless tobacco'' after the word

``event'' to read as follows:

Sec. 804.3 Definitions.

* * * * *

(d) Distributor means, for the purpose of this part, any person who

furthers the distribution of cigarettes or smokeless tobacco, whether

domestic or imported,

[[Page 26137]]

at any point from the original place of manufacture to the person who

sells or distributes the product to individuals for personal

consumption, but who does not repackage or otherwise change the

container, wrapper, or labeling of the product package. Common carriers

are not considered distributors for the purposes of this part.

* * * * *

Sec. 804.25 [Amended]

21. Section 804.25 Reports by distributors is amended in paragraph

(a)(1) by removing the words ``a device'' and adding in their place the

phrase ``contamination of a cigarette or smokeless tobacco product'';

in paragraph (a)(2) by removing the phrase ``one of its marketed

devices'' and adding in its place the phrase ``contamination of one of

its cigarette or smokeless tobacco products''; and by removing

paragraph (c).

Dated: May 1, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98-12610 Filed 5-11-98; 8:45 am]

BILLING CODE 4160-01-F