Recorded November 16, 2021 | On-Demand Webinar
Examine the legal basis and content for a 510(k). Define substantial equivalence and predicate devices. Learn how to strategize for a 510(k) submission. Discuss FDA’s 510(k) review process. 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 2021.