[Federal Register Volume 63, Number 99 (Friday, May 22, 1998)]
[Notices]
[Pages 28392-28393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13800]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0312]
Draft Guidance for Staff, Industry, and Third Parties:
Implementation of Third Party Programs Under the FDA Modernization Act
of 1997; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
[[Page 28393]]
availability of a draft guidance entitled, ``Guidance for Staff,
Industry, and Third Parties: Implementation of Third Party Programs
Under the FDA Modernization Act of 1997''. Elsewhere in this issue of
the Federal Register, FDA has published criteria to accredit or deny
accreditation to applicants who request to become Accredited Persons.
To the extent this guidance discusses recommendations and procedures
that have not been incorporated into the criteria established in the
Federal Register notice, this guidance is not final nor is it in effect
at this time. This guidance will assist those who are interested in
participating in the Third Party Program, either as persons accredited
to perform 510(k) reviews (Accredited Persons) or as applicants
pursuing clearance of 510(k) submissions consistent with the FDA
Modernization Act of 1997 (FDAMA), as well as FDA staff responsible for
implementing the program.
DATES: Written comments concerning this guidance must be received by
June 22, 1998.
ADDRESSES: Written comments concerning this guidance must be submitted
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. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance. If you do not have
access to the World Wide Web (WWW), submit written requests for single
copies of the guidance document entitled, ``Guidance for Staff,
Industry, and Third Parties: Implementation of Third Party Programs
Under the FDA Modernization Act of 1997'' on a 3.5'' disk, to the
Division of Small Manufacturers Assistance (HFZ-220), Center for
Devices and Radiological, 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.
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
On August 1, 1996, FDA established the Third Party Review Pilot
Program, a voluntary pilot program, to assess the feasibility of using
third party reviewers to improve the efficiency of the agency's review
of 510(k)s for selected low-to- moderate risk devices. Under the pilot
program, persons required to submit 510(k)s for the eligible devices
were permitted to contract with an FDA Recognized Third Party and
submit a 510(k) directly to the third party for review. Persons who did
not wish to participate in the pilot continued to submit 510(k)s
directly to FDA.
Under FDAMA, this pilot program has been codified and expanded and
FDA is required to establish and publish criteria to accredit or deny
accreditation to persons who request to perform third party reviews.
Those criteria are published elsewhere in this issue of the Federal
Register in accordance with section 210(b) of FDAMA. This guidance
document contains additional information regarding applications for
accreditation of third party reviewers, as well as additional
information about the agency's plans for implementation of the third
party review program. FDA will begin to accept applications from
prospective accredited persons beginning July 20, 1998. FDA will review
those applications in 60 days and approved Accredited Persons may begin
to submit reviews of 510(k)s on November 21, 1998. Because Accredited
Persons must participate in training prior to submitting
recommendations, applicants who wish to attend the initial training
that will be held October 14 through 16, 1998, should submit their
applications at least 60 days in advance of that date.
II. Significance of Guidance
This guidance document represents the agency's current thinking on
implementation of the third party review program. 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), which 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 document is issued as a draft Level 1 guidance
consistent with GGP's.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may also do
so using the WWW. CDRH maintains an entry on the WWW 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 ``Guidance for Staff, Industry, and
Third Parties: Implementation of Third Party Programs Under the FDA
Modernization Act of 1997,'' 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 home page is also available from a
computer or VT-100 compatible terminal by dialing 800-222-0185
(terminal settings are 8/1/N). Once 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 June 22, 1998, submit to the
Dockets Management Branch (address above) written comments regarding
this draft guidance. Two copies must be submitted of any comments sent
to the Dockets Management Branch, 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: May 19, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-13800 Filed 5-20-98; 8:45 am]
BILLING CODE 4160-01-F
