Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and Registration; Office of Management and Budget Approval; Extension of Effective Date

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; Office of Management and

Budget Approval; Extension of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; notification of approval of information collection

requirements.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the

Office of Management and Budget (OMB) has approved the collection of

information requirements in the final rule on medical device user

facility and manufacturer reporting, certification and registration. In

addition, FDA is extending to July 31, 1996, the effective date of the

final rule in response to requests and in order to allow sufficient

time for user facilities and manufacturers to implement procedures to

comply with the final rule. The final rule was published in the Federal

Register of December 11, 1995 (60 FR 63578).

EFFECTIVE DATE: July 31, 1996.

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: In the Federal Register of December 11, 1995

[[Page 16044]]

(60 FR 63578), FDA published a final rule (21 CFR parts 803 and 807)

requiring medical device user facilities and manufacturers to report

adverse events related to medical devices under a uniform reporting

system. In the preamble to the final rule (60 FR 63578 at 63596), FDA

announced that the collection of information requirements contained in

the final rule had been submitted to OMB for approval under the

Paperwork Reduction Act of 1995 (Pub. L. 104-13). The agency also

requested public comment on the information collection requirements by

January 10, 1996. The agency further stated that these collection of

information requirements would not become effective until FDA obtained

OMB approval of them, and that FDA would publish in the Federal

Register a notice of OMB's decision to approve, modify, or disapprove

them.

FDA received 26 comments regarding the information collection

requirements. Comments were reviewed by both FDA and OMB. On February

23, 1996, OMB sent FDA a notice of action stating that the collection

of information requirements are approved for use through February 28,

1999, under OMB control number 0910-0059. Persons are not required to

respond to a collection of information unless it displays a currently

valid OMB control number.

In response to comments to the information collection requirements,

FDA is changing the effective date of the final rule and providing

certain clarifications and guidance regarding requirements of the final

rule.

1. Several comments requested that the date of the final rule be

extended to allow manufacturers and user facilities additional time to

set up procedures to implement the new requirements. These comments

stated that the effective date of the final rule, April 11, 1996, would

not allow them enough time after approval of the forms to set up

reporting procedures, databases, and train personnel. FDA agrees that

reporting entities need additional time to set up reporting procedures.

FDA, on the basis of these comments on the information collection, is

extending that comment period to July 31, 1996, without further notice

and comment procedures.

The Administrative Procedure Act and FDA regulations provide that

the agency may issue a regulation without notice and comment procedures

when the agency for good cause finds (and incorporates the finding and

a brief statement of reasons thereof in the rules issued) that notice

and public procedure thereon are impracticable, unnecessary, or

contrary to the public interest (5 U.S.C. 553(b)(8); 21 CFR

10.40(e)(1)). FDA finds that there is good cause for dispensing with

notice and comment procedures to extend the effective date of the final

rule because such procedures are impracticable, unnecessary, and

contrary to the public interest.

First, notice and comment rulemaking on the extension of the

effective date is impracticable. FDA was unable to prepare and issue

notice of the extension of the effective date until April 11, 1996.

Because the final rule's effective date is April 11, 1996, there is not

enough time for FDA to solicit a new round of notice and comment before

the effective date. Although the final rule informing reporting

entities of the new requirements was published on December 11, 1995,

reporters have not known what forms would be required until the

issuance of this notice. Without the forms, reporting entities have

heretofore been unable to set up their reporting procedures and

databases or train personnel. Adequate procedures and training will

ensure that reporters generate reports that contain meaningful

information that will allow FDA efficiently evaluate adverse events.

FDA believes that reporting entities need until July 31, 1996, to set

up adequate procedures to implement the new reporting requirements.

Second, engaging in notice and comment rulemaking is unnecessary.

The public has already had two separate opportunities to comment on the

effective date; the first in response to the request in the tentative

final rule for comments, and the second in response to the request in

the request in the final rule for comments relating to the information

collection requirements. All of the comments FDA has received are in

favor of extending the effective date to allow reporters adequate time

to set up procedures to implement the new regulations. FDA does not

believe another round of notice and comment is necessary on an issue

that has already received two rounds of public comment.

Third, notice and comment rulemaking is contrary to the public

interest. Extending the effective date of the rule without notice and

comment allows reporters immediate certainty as to the timeframes that

they have to set up procedures to implement the new reporting

requirements. If FDA did not provide a definite effective date,

reporters may bear additional expense and hardship in setting up

inefficient interim procedures in order to be ready to report on a

certain date, when that date may ultimately be extended. Moreover,

because reports generated under interim procedures would be processed

without adequate time to implement proper training and procedures, such

reports may be of poor quality that would preclude both reporters and

FDA from obtaining information to evaluate adverse events effectively.

Certain knowledge of the date the regulation will be effective will

allow reporters to know the exact timeframe that will allow them to

implement procedures to effectively evaluate and submit reports.

For all the reasons stated above, FDA concludes, under 5 U.S.C.

553(b)(B) and 21 CFR 10.40(e)(1), there is good cause for extending the

effective date of the final rule without notice and comment procedures.

Consistent with its own procedural regulations, however, FDA is

providing an opportunity for comment on its decision to delay the

effective date of the final regulation until July 31, 1996.

2. Several comments stated that FDA should reconsider requiring a

baseline report (FDA Form 3417) for each model number because reporters

would have to submit many separate baseline reports for virtually

identical devices that have option and accessory packages that are

identified by a model number variation, such as a prefix or suffix.

Section 803.55 requires that a manufacturer shall submit a baseline

report for a device when the device model is first reported under

Sec. 803.50. The regulation does not require a baseline report for

every model number variation. FDA does not believe that the regulation

requires a separate baseline report for every model number variation,

if the variation could not affect the device's safety or effectiveness.

If a manufacturer groups model numbers, it should list each model

number variation on the baseline report that is included (e.g., basic

model number 900; model number variations, R900, 900C, 900D, and

R900C). FDA will match the variations of the model number reported on

form 3500A to the list of model numbers provided on the baseline

reports.

3. Comments requested further clarification on the definition of

``device family'' (Sec. 803.3(e)) that is used to identify similar

groups of devices on the manufacturer baseline report. FDA classified

and revised Sec. 803.3(e) to define ``device family'' as devices that

have the same basic design and performance characteristics related to

safety and effectiveness, intended use and function, and device

classification and product code. 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

[[Page 16045]]

introduced into commercial distribution under the same 510(k) or

premarket approval application, may be considered in grouping products

into device families.As part of implementation of the final regulation,

FDA will provide further information, guidance and examples.

4. Comments objected to the requirement on the annual certification

form for manufacturers (FDA Form 3381) that the firm certify not only

the number of reports submitted during the 12-month period for which

the certification is submitted, but also that this number constitutes

all the reportable events for which the firm is responsible during that

period.

FDA responded to similar comments in the preamble to the final rule

(60 FR 63578 at 63591). For the reasons stated therein, FDA still

believes that it is necessary and within FDA's statutory authority to

require that manufacturers certify that they have submitted all

reportable events to FDA. FDA believes that certification is an

important means of increasing the effectiveness of the Medical Device

Reporting (MDR) system. FDA, however, realizes that there may be

situations, hopefully rare, when a manufacturer, for example, did not

``become aware,'' as defined in 803.1(c) (21 CFR 803.1(c)), of

information reasonably suggesting a reportable event has occurred, and

therefore could not have submitted a report, or there may be an

occasional instance of miscounting the number of reports. FDA,

therefore, has determined that it is appropriate for manufacturers to

state that they are certifying the statements on FDA Form 3381 to the

best of their knowledge. FDA has revised the form accordingly. It now

states:

I certify that, to the best of my knowledge, the firms listed in

item 3. above either submitted the MDR indicated above during the

stated reporting period and that this number represents the

submissions for all appropriately reportable MDR events or that the

firm listed above did not receive any MDR reportable events during

this time period. I also certify that, to the best of my knowledge,

the statements and information presented in this submission are

truthful and accurate.

5. Comments objected to the requirement that annual updates to

baseline reports be submitted on the anniversary date of the initial

baseline report. The comments noted that, for companies who submit

baseline reports for numerous devices, they would have to keep track of

many different submission dates for update baseline reports. The

comments suggested that manufacturers be allowed to submit all baseline

updates on a single date, e.g., the date on which annual certification

is required.

FDA agrees with the comments and believes that it is an acceptable

interpretation of the regulation to allow an annual update on the date

on which the annual certification is due.

Section 803.55(a) requires that a manufacturer shall submit its

first baseline report ``for a device when the device model is first

reported under Sec. 803.50'' (i.e., an individual adverse event

report). Section 803.55(b) requires that each baseline report shall be

updated annually, on the anniversary month of the initial submission.

The time a manufacturer is required to submit the update of their

baseline report under Sec. 803.55(b), is therefore contingent upon the

time a manufacturer is considered to have ``first reported'' an adverse

event for a particular device model.

FDA believes that a manufacturer could interpret Sec. 803.55(a) to

mean that the first baseline report update could be submitted on the

date a firm is required to submit its next certification. Accordingly,

the firm could thereafter submit its annual baseline update report on

the date of the firm's next annual certification. For example, if a

manufacturer submits its first adverse event baseline report for a

device on March 1, 1996, it could submit its first baseline report on

the date of its next certification report, November 1, 1996.

Thereafter, it would submit its update baseline report on November 1,

1997.

FDA intends to make a guidance document on the final rule available

during April 1996, and will announce it's availability in the Federal

Register. FDA also intends to hold a nationwide teleconference by

satellite on May 7, 1996, during which FDA officials will speak on the

final rule and be available to answer questions. When more details are

available, FDA will publicize these initiatives through the Facts-on-

Demand system administered by FDA's Division of Small Manufacturers

Assistance, Center for Devices and Radiological Health, and the

electronic docket. To access this information through Facts-on-Demand

dial 1-800-899-0381 (outside MD) or 1-301-827-0111 (inside MD) and

enter document number 799.

Dated: March 30, 1996.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 96-8970 Filed 4-5-96; 3:26 pm]

BILLING CODE 4160-01-F