Medical Devices; Medical Device Distributor and Manufacturer Reporting; Certification, Registration, Listing, and Premarket Notification Submission; Stay of Effective Date; Revocation of Final Rule

SUMMARY: In response to numerous requests for the Food and Drug

Administration (FDA) to consider further comments concerning medical

device reporting (MDR) certification and U.S. designated agent

requirements, FDA is staying the effective date of these two specific

provisions of the adverse event reporting final rule that was published

in the Federal Register of December 11, 1995. Specifically, these

provisions relate to manufacturer certification and U.S. designated

agent requirements. In addition, for consistency purposes, FDA is

revoking the distributor reporting certification requirement that went

into effect on May 28, 1992.

EFFECTIVE DATE: July 23, 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

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

(21 CFR parts 803 and 807) to require medical device manufacturers,

including U.S. designated agents of foreign manufacturers, to report

adverse events related to medical devices under a uniform reporting

system (hereinafter referred to as the December 1995 final rule). This

rule also required U.S. designated agents to register, list, and submit

premarket notifications on behalf of foreign manufacturers. The

effective date of this rule was to be April 11, 1996. On April 11, 1996

(61 FR 16043), FDA extended the effective date to July 31, 1996.

Earlier, in the Federal Register of September 1, 1993 (58 FR

46514), FDA published a notice announcing that the distributor

reporting requirements, including certification, that were published as

a tentative final rule on November 26, 1991, became effective by

operation of law on May 28, 1992.

After issuing the December 1995 final rule, FDA received numerous

requests for reconsideration of the certification requirements and for

reconsideration of issues relating to U.S. designated agent

requirements. These comments led FDA to meet with the Health Industry

Manufacturers Association (HIMA) and several industry representatives

on April 19, May 23, and June 13, 1996. During these meetings, issues

concerning industry burdens and procedures relating to the

certification and U.S. designated agent requirements were put forth

that had previously not been fully considered.

Section 519(d) of the act (21 U.S.C. 360i(d)) states that each

manufacturer and distributor required to make reports under section

519(a) (21 U.S.C. 360i(a)) of the act must submit annual statements

certifying the number of reports that were filed or that no reports

were filed during the previous 12-month period. The certification

regulations for manufacturers and distributors require that the

certification include the number of MDR's filed during the previous 12-

month period and that all MDR reportable events have been submitted

(Secs. 803.57 and 804.30 (21 CFR 804.30)). FDA required the

certification that all MDR reportable events were filed on the basis of

legislative history citing the General Accounting Office report

recommending that 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).) FDA, in response to comments asking

who should certify for manufacturers, also required in the December

1995 final rule that the certifier must be the president, chief

executive officer, U.S. designated agent of a foreign manufacturer, or

other official most directly responsible for the firm's operations.

After the final rule was issued, FDA received comments taking the

position that the certifier may more appropriately be a person with

more direct involvement with the reporting requirements. Comments also

objected to requiring that the reporter certify all reportable events

have been filed on the basis that such a requirement was not

specifically required in the act, and that potential liability would be

created.

The December 1995 final rule also required that foreign firms

identify a U.S. designated agent who would be responsible for the

foreign firm's MDR reporting requirements, as well as the foreign

manufacturer's registration listing and premarket notification

submissions. After issuing the December 1995 final rule, FDA received

comments from industry objecting to these requirements as being unduly

burdensome. In response to these comments, FDA is publishing a proposed

rule, elsewhere in this issue of the Federal Register, addressing the

certification and U.S. designated agent issues. FDA intends that the

requirements relating to distributor and manufacturer certification,

and to U.S. designated agents, will not be in effect until at least 75

days after the date of publication in the Federal Register of a new

final rule.

The Administrative Procedure Act (Pub. L. 79-404) 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); Sec. 10.40(e)(1) (21 CFR 10.40 (e)(1)).) FDA finds

that there is good cause for dispensing with notice and comment

procedures to stay the effective date of the manufacturer certification

and U.S. designated agent reporting provisions, (Secs. 803.3(n)(4),

803.57, 803.58, 807.3(r), 807.20(a)(6), and 807.40) and for revoking

the certification requirements for distributors (Sec. 804.30) because

such notice and comment procedures are impracticable and contrary to

the public interest.

Notice and comment rulemaking on the postponement of manufacturer

certification and U.S.designated agent requirements is impracticable.

FDA was not aware of a number of significant issues relating to these

requirements until after publication of the December 1995 final rule.

Since that time, FDA has had numerous meetings with HIMA and industry

representatives and internal meetings to decide the best approach to

understand and resolve issues concerning the rule. The last meeting

with HIMA and industry representatives occurred on June 13, 1996.

Without the issuance of a stay under good cause procedures, the

certification and U.S. designated agent requirements would become

effective on July 31, 1996.

In addition, notice and comment rulemaking, in this instance, on

the stay of the present certification requirements would be contrary to

the public interest. Because there is not enough time to allow notice

and comment on the issue

[[Page 38347]]

of staying the effective date before it occurs, the certification and

U.S. designated agent requirements would be in effect only for the

interim period between the effective date of the final manufacturer

rule, July 31, 1996, and the date the agency expects that these

provisions, after issuance of a reproposed rule, would be revised and

become final a second time. This result would cause industry to

implement costly certification and U.S. designated agent procedures and

contractual arrangements that would most likely have to be changed with

additional cost after these requirements are reproposed and

refinalized.

It is also against the public interest to have a certification

requirement in effect for distributors, while not having such a

requirement in effect for manufacturers. The MDR system is intended to

operate as a uniform reporting system where user facilities,

distributors, and manufacturers efficiently share, forward, and provide

complementary information on the same adverse events. Having a system

whereby distributors certify reports and manufacturers do not certify

reports would hinder the uniformity of this program and result in

regulatory confusion.

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

553(b)(8) and Sec. 10.40(e)(1), that there is good cause for staying

the effective date of the certification and U.S. designated agent

provisions of the December 1995 final rule and for revoking the

distributor certification requirements of the May 28, 1992 rule.

Foreign manufacturers have a responsibility for compliance with all

medical device reporting requirements which will not be affected by the

stay of the effective date of the U.S. designated agent requirements.

This is because the December 1995 final rule contained a significant

change regarding foreign manufacturers. The original medical device

reporting regulation that became effective December 13, 1984, defined a

manufacturer who was required to submit MDR reports as any person who

is required to register under part 807. Because foreign manufacturers

are not required to register, the December 1984 regulation did not

apply to them. The revised December 1995 final rule, however, no longer

defines a manufacturer who is required to report adverse events as a

person who is required to register under part 807. Rather, under

Sec. 803.3(n) of the December 1995 final rule, a manufacturer means any

person who manufactures, prepares, propagates compounds, assembles, or

processes a device by chemical, physical, biological, or other

procedure. Accordingly, foreign manufacturers clearly fit within the

definition of manufacturers who are required to submit MDR's under the

December 1995 final rule. This means that, on July 31, 1996, foreign

manufacturers will be fully subject to the same requirements of part

803 applicable to all domestic manufacturers. This includes, but is not

limited to, the requirements for written procedures (Sec. 803.17), MDR

event files (Sec. 803.18), individual adverse event reports

(Secs. 803.50 and 803.52), 5-day reports (Sec. 803.53), baseline

reports (Sec. 803.55), and supplemental reports (Sec. 803.56). In

addition, existing regulations will remain in effect pending the stay

that permits foreign manufacturers to register (Sec. 807.40(a)) and

submit premarket notifications (Sec. 807.81), and require them to list

their devices (Sec. 807.40(b)).

List of Subjects

21 CFR parts 803 and 804

Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR part 807

Confidential business information, 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, 21 CFR parts

803, 804, and 807 are amended as follows:

PART 803--MEDICAL DEVICE REPORTING

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR

MANUFACTURERS AND DISTRIBUTORS OF DEVICES

1. In the revision of part 803 and the amendments to part 807 which

were published at 60 FR 63578 (December 11, 1995), the effective date

of which was extended until July 31, 1996, at 61 FR 16043 (April 11,

1996), the following provisions are stayed until further notice:

A. Secs. 803.3(n)(4), 803.57, and 803.58.

B. The addition of Sec. 807.3(r) and 807.20(a)(6); and

C. The revision of Sec. 807.40.

PART 804--MEDICAL DEVICE DISTRIBUTOR REPORTING

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

follows:

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).

Sec. 804.30 [Removed]

3. Section 804.30 is removed.

Dated: July 16, 1996.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 96-18700 Filed 7-19-96; 2:26 pm]

BILLING CODE 4160-01-F