[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Notices]
[Pages 36240-36241]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17600]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Draft Guidance for Staff, Industry and Third Parties: Third Party 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availability of a draft guidance entitled ``Draft Guidance for Staff, 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 (Medical Devices Annex), FDA has 
agreed to designate Conformity Assessment Bodies (CAB's). CAB's will be 
third parties (i.e., private individuals or organizations outside of 
FDA) authorized to perform premarket and quality system evaluations 
consistent with the Medical Devices Annex. Assuming the MRA enters into 
force and a final rule becomes effective, when finalized, this draft 
guidance will apply to CAB's seeking to be designated under the Medical 
Devices Annex, and it 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 Medical 
Devices Annex.
DATES: Written comments by August 3, 1998.

ADDRESSES: Submit written comments on the guidance to the Dockets 
Management Branch, (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Comments should be 
identified with the docket number found in brackets in the heading of 
this document. If you do not have access to the World Wide Web, submit 
written requests for single copies of the guidance document entitled 
``Draft Guidance for Staff, Industry and Third Parties: Third Party 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 401-443-8818. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance.

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

    FDA has participated in negotiations on an international agreement 
on medical devices concluded in June 1997 between the United States and 
the European Community (EC). These negotiations resulted in the 
drafting of the MRA, which includes a special section pertaining to 
medical devices and is referred to as the Medical Devices Annex. After 
completion of a 3-year transition period, the Medical Devices Annex 
provides for normal endorsement of premarket and quality system 
evaluation reports of conformity assessment produced by equivalent 
third parties, the CAB's.
    The MRA was signed in London on May 18, 1998, but it has not 
entered into force. FDA has published a proposed rule on the portions 
of the MRA affecting FDA-regulated products (63 FR 17744, April 10, 
1998); the comment period closed on May 11, 1998.
    In order to establish confidence in the conformity assessment 
process, CAB's will be required to participate in rigorous joint 
activities 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 intends to use 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 assess 
potential U.S. CAB's seeking to be designated under the Medical Devices 
Annex, to evaluate medical devices produced for the EC market. FDA will 
consider the recommendations made by the recognized accreditation 
bodies under NVCASE from June 1, 1998, to October 1, 1998, and then 
designate U.S. CAB's that meet criteria for technical competence 
established in the Medical Devices Annex. This draft guidance provides 
information regarding the process for CAB's to become eligible for 
designation under the Medical Devices Annex.

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on guidance for staff, industry, third parties, and 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. This guidance is not final 
nor is it in effect at this time.
    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 draft guidance may do 
so using the World Wide Web. CDRH maintains

[[Page 36241]]

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 ``Draft 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.
    A text-only version of the CDRH Web site is also available from a 
computer or VT-100 compatible terminal by dialing 800-222-0185. The 
terminal settings are 8/1/N. After the modem answers, press Enter 
several times and then select menu choice 1: FDA BULLETIN BOARD 
SERVICE. From there follow instructions for logging in, and at the BBS 
TOPICS PAGE, arrow down to the FDA Home Page (do not select the first 
CDRH entry). Then select Medical Devices and Radiological Health. From 
there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general 
information, or arrow down for specific topics.

IV. Comments

    Interested persons may, on or before (insert date 30 days after 
publication in the Federal Register), submit to Dockets Management 
Branch (address above) written comments regarding this draft guidance. 
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 brackets in the heading of this document. The guidance 
document and received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 24, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-17600 Filed 7-1-98; 8:45 am]
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