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

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

Jemin Dedania, Director of Regulatory Affairs, Hogan Lovells US LLP

This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in October 2024.

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