[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Draft Guidance for Staff, Industry and Third Parties: Third Party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availability of a draft guidance entitled ``Draft Guidance for Staff,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force and a final rule becomes effective, when finalized, this draft
guidance will apply to CAB's seeking to be designated under the Medical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``Draft Guidance for Staff, Industry and Third Parties: Third Party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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