[Federal Register Volume 64, Number 22 (Wednesday, February 3, 1999)]
[Notices]
[Pages 5302-5303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2509]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0375]


Guidance for Staff, Industry and Third Parties: Third Party 
Programs Under the Sectoral Annex on Medical Devices to the Agreement 
on Mutual Recognition Between the United States of America and the 
European Community; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Guidance for Staff, Industry and 
Third Parties: Third Party Programs Under the Sectoral Annex on Medical 
Devices to the Agreement on Mutual Recognition Between the United 
States of America and the European Community (MRA).'' Under the 
Sectoral Annex on Medical Devices (Annex), FDA has agreed to designate 
conformity assessment bodies (CAB's) as third parties (i.e., 
organizations outside of FDA) authorized to perform premarket and 
quality system evaluations consistent with the Annex. This guidance 
will assist those who are interested in participating in this program 
as CAB's or as applicants pursuing premarket and quality system 
evaluations consistent with the Annex.

DATES: Written comments may be submitted at any time.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the guidance. If you do not have access to the 
World Wide Web, submit written requests for single copies of the 
guidance entitled ``Guidance for Staff, Industry and Third Parties: 
Third Party Programs Under the Sectoral Annex on Medical Devices to the 
Agreement on Mutual Recognition Between the United States of America 
and the European Community (MRA)'' on 3.5'' diskette 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 request, or fax your request to 301-443-
8818. Written comments concerning this guidance may be submitted at any 
time to the contact person listed below.

FOR FURTHER INFORMATION CONTACT: John F. Stigi, Division of Small 
Manufacturers Assistance (HFZ-220),

[[Page 5303]]

Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-6597 or 
FAX 301-443-8818.

SUPPLEMENTARY INFORMATION:

I. Background

    The United States and the European Community (EC) exchanged letters 
on October 30, 1998, which brought the MRA into force on December 7, 
1998. FDA published a final rule on the MRA on November 6, 1998 (63 FR 
60122).
    In the MRA negotiations, FDA led the negotiations on the Annex to 
the MRA between the United States and the EC. These negotiations 
resulted in the drafting of the MRA, which includes a special section 
pertaining to medical devices that is referred to as the Annex. The 
Annex provides for a 3-year transition period. After the transition 
period FDA and the EC may normally endorse premarket and quality system 
evaluation reports provided by equivalent third parties, the CAB's.
    In order to establish confidence in the conformity assessment 
process, CAB's will be required to participate in rigorous joint 
exercises to demonstrate their proficiency to conduct evaluations. Upon 
implementation of this program, CAB evaluations will be exchanged and 
normally endorsed by both FDA and the EC for the marketing of medical 
devices.
    FDA is using the National Voluntary Conformity Assessment System 
Evaluation (NVCASE) administered by the National Institute of Standards 
and Technology (NIST) of the U.S. Department of Commerce to recognize 
one or more accreditation bodies that, in turn, will accredit potential 
U.S. CAB's seeking to be designated under the Annex to evaluate medical 
devices produced for the EC market. FDA has considered the 
recommendations made by the NIST under NVCASE and has designated the 
U.S. CAB's that meet criteria for technical competence established in 
the Annex, for possible participation in transition activities.
    In the Federal Register of July 2, 1998 (63 FR 36247), FDA 
published information regarding the process for CAB's to become 
eligible for designation under the Annex. On the same date, the agency 
announced the availability of a draft guidance on the third party 
program (63 FR 3621). The agency received three comments on the draft 
guidance. FDA has reviewed these comments and has made no significant 
revisions in the guidance in response to these comments. The agency 
has, however, included additional information regarding conflicts of 
interest, including additional examples of situations that would 
indicate a potential conflict of interest.

II. Significance of Guidance

    This guidance represents the agency's current thinking on 
``Guidance for Staff, Industry, and Third Parties: Third Party Programs 
Under the Sectoral Annex on Medical Devices to the Agreement on Mutual 
Recognition Between the United States of America and the European 
Community.'' It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the applicable statute, 
regulations, or both.
    The agency has adopted good guidance practices (GGP's) that set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This guidance is issued as a Level 1 guidance consistent with 
GGP's.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so 
using the World Wide Web. CDRH maintains an entry on the World Wide Web 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with access to the Web. 
Updated on a regular basis, the CDRH Home Page includes the ``Guidance 
for Staff, Industry and Third Parties: Third Party Programs Under the 
Sectoral Annex on Medical Devices to the Agreement on Mutual 
Recognition Between the United States of America and the European 
Community (MRA),'' device safety alerts, access to Federal Register 
reprints, information on premarket submissions including lists of 
approved applications and manufacturers' addresses, small manufacturers 
assistance, information on video conferencing and electronic 
submissions, mammography matters, and other device-oriented 
information. The CDRH Home Page may be accessed at ``http://
www.fda.gov/cdrh''.

IV. Comments

    Interested persons may, at any time, submit written comments 
regarding this guidance to the contact person listed above. Such 
comments will be considered when determining whether to amend the 
current guidance.

    Dated: January 19, 1999.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 99-2509 Filed 2-2-99; 8:45 am]
BILLING CODE 4160-01-F