FDA Submission Pathways with EIT Health Alumni

RAQA Today
01/04/2021 1h 17min

Listen "FDA Submission Pathways with EIT Health Alumni"

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Episode Synopsis

Determining which FDA submission pathway best applies to your medical device or product can be daunting. Listen in as Michelle explains how to decide if your product qualifies for a 510(k), PMA, de novo or 510(k) exempt submission - as well as the basic requirements for each.

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