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

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Recorded November 16, 2022 | On-Demand Webinar

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.

This session was recorded as part of FDLI’s virtual Introduction to Medical Device Law and Regulation course in November 2022.

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