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.

Michael Kasser, Director of Regulatory Sciences, Hogan Lovells US LLP

This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in March 2021. 

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