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 October 29–30, 2024
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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