U.S. FDA’s 510(k), IDE, and PMA Documentation, Submission and Approval Process
July 17, 2018 - Online Event ON CAWebinar Compliance
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What are the various routes to US FDA device clearance / approval? The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and some must go through the extremely costly, time consuming and rigorous PMA approval process. What is the De Novo provision? The US classification system. For clinical trials, an IDE (Investigational Device Exemption) submission is required. The FDA holds companies responsible for filing new 510(k)s, or IDEs / PMAs when new products are to be marketed in the U.S., or when existing products and/or their Indications for Use are changed.