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.

Véronique Li, Senior Medical Device Regulation Expert, Hyman, Phelps & McNamara, PC

This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in April 2025.

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Kiana Walker2025-04-14T15:29:10-04:00