510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review." This draft guidance provides FDA's current thinking regarding the 510(k) Third Party (3P510k) Review Program and review of Emergency Use Authorizations (EUA) requests by a third party review organizations (3PEUA review). The 3P510k Review Program and 3PEUA review create an alternative process for manufacturers to seek review of 510(k) submissions and EUA requests to assist FDA in reviewing in a timely manner. This draft guidance is not final nor is it for implementation at this time.
Abstract as published in the Federal Register.
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