RESCHEDULED: Hearing on "FDA User Fee Reauthorization: Ensuring Safe and Effective Medical Devices"
The Subcommittee on Health of the Committee on Energy and Commerce held a hybrid hearing that included both in-person and remote attendance on Wednesday, March 30, 2022, at 9:00 a.m. This hearing took place in the John D. Dingell Room, 2123 of the Rayburn House Office Building, as well as remotely using Cisco Webex online video conferencing. The hearing is entitled, "FDA User Fee Reauthorization: Ensuring Safe and Effective Medical Devices." This hearing was originally scheduled for 10:00 a.m. (EDT) on Wednesday March 30, 2022.
Key Documents
Memorandum from Chairman Pallone to the Subcommittee on Health
Opening Statement from Chairman Pallone as prepared for delivery
Opening Statement from Subcommittee Chairwoman Eshoo as prepared for delivery
Livestream
Legislation
H.R. 7084, the “Protecting and Transforming Cyber Health Care Act of 2022” or the “PATCH ACT”
H.R. 7192, the “Diagnostic Device Advisory Committee Act”
H.R. ____, the “Medical Device User Fee Amendments of 2022”
Witnesses
Panel I
Jeff Shuren, M.D.
Director, Center for Devices and Radiological Health
Food and Drug Administration
Panel II
Richard J. Kovacs, M.D.
Q.E. and Sally Russell Professor of Medicine
Indiana University School of Medicine
Chief Medical Officer, American College of Cardiology
Mark Leahey
President & CEO
Medical Device Manufacturers Association
Janet Trunzo
Senior Executive Vice President, Technology and Regulatory Affairs
Advanced Medical Technology Association (AdvaMed)
Diane Wurzburger
Executive of Regulatory Affairs
GE Healthcare