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.
- +$100 for nonmembers
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