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

A session from FDLI's Introduction to Medical Device Law and Regulation
Recorded November 16–17, 2022

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.

Sarah Rys, Sr. Principal Regulatory Affairs Specialist, Medtronic

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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Kiana Walker2022-12-16T12:14:08-05:00