FDA Medical Device Approval Pathways

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Presentation transcript:

Gail A. Van Norman BTS 2016;1:277-287 FDA Medical Device Approval Pathways* *Early consultation with Food and Drug Administration (FDA) through pre-submission meetings in strongly encouraged; the FDA can help determine which pathway and applications are needed, as well as determine whether clinical trials are necessary. FFDCA = Federal Food, Drug, and Cosmetics Act; HDE = human device exemption; IDE = investigational device exemption; IRB = Institutional Review Board; PMA = pre-market approval; PMN = pre-market notification. Gail A. Van Norman BTS 2016;1:277-287 The Authors