[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
