Medical Device Premarket Approval Applications (PMA) and the Humanitarian Device Exemption (HDE): An Introduction
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.
Lina R. Kontos, Partner, Hogan Lovells US LLP
This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in October 2023.