[Federal Register Volume 63, Number 211 (Monday, November 2, 1998)]
[Notices]
[Pages 58746-58747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29275]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0312]
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
availability of a guidance entitled ``Guidance for Staff, Industry, and
Third Parties: Implementation of Third Party Programs Under the FDA
Modernization Act of 1997.'' The FDA Modernization Act of 1997 (FDAMA)
codified and expanded the Third Party Review Pilot Program providing
for review of certain premarket notification (510(k)) submissions by
private parties outside of the Center for Devices and Radiological
Health (CDRH). This guidance will assist those who are interested in
participating in this program, either as persons accredited to perform
510(k) reviews (Accredited Persons) or as applicants pursuing clearance
of 510(k) submissions through use of Accredited Persons, as well as FDA
staff responsible for implementing the program.
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written comments concerning this guidance to the
contact person listed below. If you do not have access to the World
Wide Web (WWW), submit written requests for single copies of the
guidance 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 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. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
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
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 were published in the Federal Register of May 22, 1998
(63 FR 28388). On the same date, the agency announced the availability
of a draft guidance pertaining to the third party review program (63 FR
28392). The agency received three comments on the draft guidance. FDA
has reviewed the comments and has made some revisions to the guidance
in response to the comments. The agency also has included additional
information regarding conflicts of interest. This includes additional
examples of conditions that could indicate an appearance of a conflict
of interest and a statement that applications from prospective third
parties should include the written policies and procedures that have
been established to ensure that contract employees involved in the
evaluation of 510(k)'s are also free from conflicts of interest.
FDA will begin to accept applications from prospective accredited
persons beginning July 20, 1998. FDA will
[[Page 58747]]
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 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, 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
has been issued under the agency's procedures for a Level 1 guidance
document.
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, at any time, submit written comments
regarding this final guidance to the contact person listed above.
Comments will be considered when determining whether to amend the
current guidance.
Dated: October 26, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-29275 Filed 10-30-98; 8:45 am]
BILLING CODE 4160-01-F
