Recorded October 11, 2023 | On-Demand Webinar
Access to recordings of virtual introductory courses is limited to one year from the date of purchase as we update programs annually.
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.
This session was recorded as part of FDLI’s virtual Introduction to Medical Device course in October 2023.