Recorded April 13, 2022 | On-Demand Webinar
Learn the required elements and FDA review considerations for Premarket Approval applications. Understand the required contents and FDA review considerations for Humanitarian Device Exemption (HDE) applications. Recognize post-approval and post-marketing considerations for approved PMAs and HDEs.
This session was recorded as part of FDLI’s virtual Introduction to Medical Device Law and Regulation course in April 2022.