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.
Deborah Baker-Janis, Senior Director, NSF International
This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in November 2022.
DEBORAH BAKER-JANIS joined NSF International in 2013 after working in the medical device industry for over 10 years, including in both regulatory affairs and product development. Her experience includes the development of pre‐clinical testing protocols, risk documentation, quality system and regulatory affairs standard operating procedures, sales training materials, safety reports and domestic and international regulatory strategies and submissions. Ms. Baker‐Janis has supported the development and commercialization of a wide range of products including cardiovascular devices, general and plastic surgery devices, gastroenterology devices and general hospital devices. Her educational background is in biomedical engineering.Get Access
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