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RESCHEDULED: Hearing on "FDA User Fee Reauthorization: Ensuring Safe and Effective Medical Devices"

Date: 
Wednesday, March 30, 2022 - 9:00am
Location: 
Hybrid Hearing in the John D. Dingell Room, 2123 of the Rayburn House Office Building, and Cisco Webex

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

Testimony

 

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

Testimony

 

Mark Leahey
President & CEO
Medical Device Manufacturers Association

Testimony

 

Janet Trunzo
Senior Executive Vice President, Technology and Regulatory Affairs
Advanced Medical Technology Association (AdvaMed)

Testimony

 

Diane Wurzburger
Executive of Regulatory Affairs
GE Healthcare

Testimony

 

Issues: