[Federal Register Volume 63, Number 99 (Friday, May 22, 1998)]
[Notices]
[Pages 28392-28393]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-13800]


-----------------------------------------------------------------------

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 Draft Guidance for Staff, Industry, and Third Parties: 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.

-----------------------------------------------------------------------

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availability of a draft guidance entitled, ``Guidance for Staff, 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section for electronic access to the draft guidance.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