[Federal Register Volume 65, Number 192 (Tuesday, October 3, 2000)]
[Notices]
[Pages 59006-59007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25351]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1492]


Mutual Recognition Agreement, Medical Device Annex; Confidence 
Building Activities: Availability of Draft Guidances

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of two draft guidance documents entitled ``Implementation 
Plan for the Mutual Recognition Agreement Between the European Union 
and the United States of America: Confidence Building Programme: 
Overview'' and ``Implementation Plan for the Mutual Recognition 
Agreement Between the European Union and the United States of America: 
Procedures for Joint Confidence Building.'' These draft guidance 
documents have been prepared jointly by FDA and the Commission for the 
European Communities (CEC's) and are intended to serve as guidance for 
all interested parties participating in confidence building activities 
under the medical device annex to the Mutual Recognition Agreement 
(MRA). While these draft guidance documents reflect the latest European 
Union (EU) edits, they have not been accepted by FDA. FDA is requesting 
comments on these documents. FDA plans to provide its comments on these 
documents and any stakeholder comments the agency receives to the 
CEC's.

DATES: Submit written comments on these draft guidance documents to 
ensure their adequate consideration in preparation of the final 
document by November 2, 2000.

ADDRESSES: Submit written comments concerning these draft guidance 
documents to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Comments should be identified with the docket number found in brackets 
in the heading of this document. To expedite the review process, if 
possible, FDA requests that you send a copy of your comments to the 
contact person, Christine Nelson (address below) or by e-mail to 
[email protected]. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to these documents. If you do not have 
access to the Internet, submit written requests for single copies on a 
3.5" diskette of the draft guidance documents listed above to the 
Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health, Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive 
labels to assist that office in processing your requests, or fax your 
request to 301-443-8818.

FOR FURTHER INFORMATION CONTACT:  Christine Nelson, Office of Health 
and Industry Programs (HFZ-220), Center for Devices and Radiological 
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850, 301-443-6597, ext. 128, FAX 301-443-8818, or e-mail 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On June 27, 1997, the United States and the EU signed an MRA that 
covers a variety of product sectors including telecommunication, 
electrical safety, recreational crafts, pharmaceuticals, and medical 
devices. The Medical Device Annex to the MRA became effective December 
7, 1998, and initiated a 3-year transition period during which both 
sides will engage in confidence building activities. Article 7 of the 
Medical Device Annex provides that FDA and the CEC's will establish a 
joint confidence building program to provide sufficient evidence of the 
capabilities of the nominated Conformity Assessment Bodies (CAB's) to 
perform quality system or product evaluations to the specifications of 
the parties. After the 3-year period, the Medical Device Annex would 
become operational if the confidence building activities are 
successfully completed.
    The Medical Devices Annex covers the exchange of quality systems 
evaluation/inspection reports for all medical devices and premarket 
evaluations for selected low to medium risk devices. A European CAB can 
conduct inspections for all classes of devices and 510(k) evaluations 
for selected devices based on FDA requirements for European device 
manufacturers who wish to market their devices in the United States. 
Similarly, a U.S. CAB can conduct quality system or type-testing 
evaluations based on EU requirements for U.S. device manufacturers who 
wish to market their devices in the EU. In addition, an alert system 
would be set up during the transition period and maintained thereafter, 
by which the parties will notify each other when there is an immediate 
danger to public health. As part of that system, each party will

[[Page 59007]]

notify the other party of any confirmed problem reports, corrective 
actions, or recalls.
    These two draft guidance documents entitled ``Implementation Plan 
for the Mutual Recognition Agreement Between the European Union and the 
United States of America: Confidence Building Programme: Overview'' and 
``Implementation Plan for the Mutual Recognition Agreement Between the 
European Union and the United States of America: Procedures for Joint 
Confidence Building'' provide guidance on how to implement confidence 
building activities under the Medical Device Annex of the MRA for 
quality system evaluations and product evaluations. Guidance on 
implementing an alert system will be issued separately at another time.

II. Significance of Guidance

    These draft guidance documents are intended to provide guidance. 
The draft guidance documents were developed by FDA and the European 
Commission (EC) to further implementation of the MRA. This current 
draft represents the EC's latest edits. FDA will be providing comments 
to the EC and proposing certain changes that are described in the ``FDA 
Concerns'' section of the guidance document. These draft guidance 
documents do not create or confer any rights for or on any person and 
do not operate to bind FDA or the public. An alternative approach may 
be used if such approach satisfies the requirements of the applicable 
statute, regulations, or both.
    The agency has adopted good guidance practices (GGP's) which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). These guidance documents are issued as a draft Level 1 guidance 
consistent with GGP's.

III. Electronic Access

    Persons interested in obtaining copies of these draft guidance 
documents may do so through the Internet at www.fda.gov/cdrh/mra.

IV. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding these draft guidance 
documents by November 2, 2000. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments should 
be identified with the docket number found in brackets in the heading 
of this document. A copy of the draft guidance documents and received 
comments may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday. To expedite receipt and review, FDA 
requests, if possible, that a copy of your comments be sent to the 
contact person (address above) or by e-mail to [email protected].

    Dated: September 22, 2000.
William K. Hubbard,
Senior Associate, Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-25351 Filed 10-2-00; 8:45 am]
BILLING CODE 4160-01-F