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

Subcommittee on Health (Committee on Energy and Commerce)

Wednesday, March 30, 2022 (9:00 AM)

Meeting was rescheduled to the time and date listed above.
2123 RHOB
Washington, D.C.
This will be a hybrid hearing held in 2123 Rayburn House Office Building, as well as remotely on the Committee's Cisco Webex Platform. The hearing will be live streamed on the Committee's website at https://energycommerce.house.gov.

Witnesses

Panel one

Dr. Jeff Shuren
Director, Center for Devices and Radiological Health, Food and Drug Administration

Added 03/28/2022 at 11:11 AM
  • Witness Statement [PDF] Added 03/28/2022 at 12:49 PM
  • Response to Questions for the Record [PDF] Added 09/19/2022 at 12:45 PM
  • Witness Truth in Testimony [PDF] Added 03/28/2022 at 02:06 PM
  • Witness Biography [PDF] Added 03/28/2022 at 12:49 PM

Panel two

Dr. Richard J. Kovacs
Q.E. and Sally Russell Professor of Medicine, Indiana University School of Medicine, Chief Medical Officer, American College of Cardiology

Added 03/28/2022 at 11:11 AM
  • Witness Statement [PDF] Added 03/29/2022 at 09:23 AM
  • Witness Truth in Testimony [PDF] Added 03/29/2022 at 09:23 AM
  • Witness Biography [PDF] Added 03/29/2022 at 09:24 AM

Mr. Mark Leahey
President & CEO, Medical Device Manufacturers Association

Added 03/28/2022 at 11:11 AM
  • Witness Statement [PDF] Added 03/29/2022 at 09:23 AM
  • Witness Truth in Testimony [PDF] Added 03/29/2022 at 09:23 AM
  • Witness Biography [PDF] Added 03/29/2022 at 09:55 AM

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

Added 03/28/2022 at 11:11 AM
  • Witness Statement [PDF] Added 03/28/2022 at 12:49 PM
  • Witness Truth in Testimony [PDF] Added 03/28/2022 at 12:49 PM
  • Witness Biography [PDF] Added 03/28/2022 at 12:49 PM

Ms. Diane Wurzburger
Executive of Regulatory Affairs, GE Healthcare

Added 03/28/2022 at 11:11 AM
  • Witness Statement [PDF] Added 03/28/2022 at 02:06 PM
  • Witness Truth in Testimony [PDF] Added 03/29/2022 at 10:19 AM
  • Witness Biography [PDF] Added 03/29/2022 at 10:19 AM

Text of Legislation

  • H.R. 7084, the “Protecting and Transforming Cyber Health Care Act of 2022” or the “PATCH ACT” [PDF]
  • H.R. 7192, the “Diagnostic Device Advisory Committee Act [PDF]
  • H.R. ____, the “Medical Device User Fee Amendments of 2022” [PDF]

Support Documents

  • Hearing Notice [PDF]
  • Hearing Notice - Time Change [PDF] Added 03/27/2022 at 10:05 PM
  • Briefing Memo [PDF] Added 03/28/2022 at 11:11 AM
  • Document for the Record - A letter from public interest and healthcare organizations [PDF] Added 04/28/2022 at 12:50 PM

Member Statements

  • Opening Statement of Rep. Anna G. Eshoo, Chairwoman of the Subcommittee on Health [PDF] Added 04/28/2022 at 12:50 PM
  • Opening Statement of Rep. Brett Guthrie, Ranking Member of the Subcommittee on Health [PDF] Added 04/28/2022 at 12:59 PM
  • Opening Statement of Rep. Frank Pallone, Jr., Chairman of the Full Committee [PDF] Added 04/28/2022 at 12:59 PM
  • Opening Statement of Rep. Cathy McMorris Rodgers, Ranking Member of the Full Committee [PDF] Added 04/28/2022 at 12:59 PM

Hearing Record

  • Preliminary Transcript [PDF] Added 04/28/2022 at 12:50 PM
  • Member Attendance [PDF] Added 04/28/2022 at 12:59 PM

First Published: March 23, 2022 at 07:07 PM
Last Updated: December 9, 2022 at 11:27 AM


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