[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]
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