Review the statutory framework of how the government regulates the medical device industry. Define “device” and differentiate between the medical device classes. Explore the nuances of combination products. Examine the purpose and outcome of medical device user fees. Review the FDA’s organizational structure as well as other agencies that impact medical device regulation, their respective roles and jurisdiction, and how and when to communicate with FDA.
Sousan Sheldon, Independent Consultant, EAS Consulting Group
This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in March 2021.