Recorded April 7, 2020 | 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 April 2020.