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Zdrowie i gospodarka · 22.05.1998

Draft Guidance for Staff, Industry, and Third Parties: Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled, ``Guidance for Staff, Industry, and Third Parties: Implementation of Third Party Programs Under the FDA Modernization Act of 1997''.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.

Source: Federal Register — Food and Drug AdministrationOpen original release →