Zdrowie i gospodarka · 02/11/1998

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 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.