510(k) Third Party Review Program – Latest Guidance, Changes, Challenges, and Opportunities
February 6, 2019 - Online Event ON CAWebinar Compliance
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This webinar will examine the FDA’s latest draft guidance, “510(k) Third Party Review Program, Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations” and the important areas for regulated companies to focus in the coming year onward. The 510(k) Third Party (3P) Review Program (formally known as the Accredited Persons (AP) Program) is authorized under section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Under this authority, FDA recognizes third parties to review premarket notification (510(k)) submissions and recommend the initial classification of certain devices. This establishes a process for recognition of qualified third parties to conduct the initial review of 510(k) submissions for certain low-to-moderate risk devices eligible for review under the 3P Review Program.