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[Federal Register: November 2, 1998 (Volume 63, Number 211)] [Notices] [Page 58746-58747] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr02no98-81] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
Updated 11/2/1998
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