An Introduction to the Medical Device Approval Process: Premarket Notification 510(k) and De Novo Requests

Examine the legal basis and content for a 510(k). Define substantial equivalence and predicate devices. Learn how to strategize for a 510(k) submission. Discuss FDA’s 510(k) review process. Learn what a de novo request is and when it will be accepted.

Jeffrey K. Shapiro, Director, Hyman, Phelps & McNamara, PC

This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in April 2020. 

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