Hearing: Examining Improvements to the Regulation of Medical Technologies

Subcommittee on Health (Committee on Energy and Commerce)

Tuesday, May 2, 2017 (10:00 AM)

2123 RHOB
Washington, D.C.

Witnesses

Panel one

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

Added 04/28/2017 at 02:54 PM
  • Witness Statement [PDF] Added 05/01/2017 at 05:55 PM
  • Truth in Testimony and CV [PDF] Added 05/01/2017 at 05:55 PM

Panel two

Mr. Robert Kerwin
General Counsel, International Association of Medical Equipment Remarketers and Servicers

Added 04/28/2017 at 02:54 PM
  • Witness Statement [PDF] Added 05/01/2017 at 12:56 PM
  • Truth in Testimony and CV [PDF] Added 05/01/2017 at 05:55 PM

Dr. Frank Lin
Associate Professor of Otolaryngology, Johns Hopkins University, Head and Neck Surgery, Geriatric Medicine, Mental Health, and Epidemiology

Added 04/28/2017 at 02:54 PM
  • Witness Statement [PDF] Added 05/01/2017 at 12:56 PM
  • Truth in Testimony and CV [PDF] Added 05/01/2017 at 05:55 PM

Dr. Thomas Powers
Powers Consulting, LLC

Added 04/28/2017 at 02:54 PM
  • Witness Statement [PDF] Added 05/01/2017 at 03:58 PM
  • Truth in Testimony and CV [PDF] Added 05/01/2017 at 05:55 PM

Mr. Joe Robinson
Senior Vince President, Philips North America, Health Systems Solutions

Added 04/28/2017 at 02:54 PM
  • Witness Statement [PDF] Added 05/01/2017 at 12:56 PM
  • Truth in Testimony and CV [PDF] Added 05/01/2017 at 05:55 PM

Ms. Patricia Shrader
Vice President, Global Regulatory Affairs, Medtronic

Added 04/28/2017 at 02:54 PM
  • Witness Statement [PDF] Added 05/01/2017 at 12:56 PM
  • Truth in Testimony and CV [PDF] Added 05/01/2017 at 05:55 PM

Text of Legislation

  • H.R. 1652, the Over-the-Counter Hearing Aid Act of 2017 [PDF]
  • H.R. 1736, to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications [PDF]
  • H.R. 2009, Fostering Innovation in Medical Imaging Act [PDF]
  • H.R. 2118, Medical Device Servicing and Accountability Act [PDF]

Support Documents

  • Hearing Notice [PDF] Added 04/25/2017 at 03:27 PM
  • Background Memo [PDF] Added 04/28/2017 at 12:18 PM
  • Document for the Record - Rep. Blackburn - Letter from Senators [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Blackburn - Consumer Technology Association Letter [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Brooks - TriMedx Statement [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Kennedy - AARP Letter [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Kennedy - ADA Statement [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Kennedy - Consumers Union Letter [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Kennedy - Hearing Loss Association of America Letter [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Kennedy - National Committee to Preserve Social Security and Medicare Letter [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Kennedy - Bose Letter [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Burgess - American Academy of Otolaryngology- Head and Neck Surgery Statement [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Burgess - ADA Statement [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Burgess - American Speech-Language-Hearing Association Statement [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Burgess - Consumer Reports Article [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Burgess - Consumer Technology Association Letter [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Burgess - Consumers Union Letter [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Burgess - Aramark Letter [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Burgess - Repair.org Statement [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Burgess - International Hearing Society Statement [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Burgess - Association of Medical Deice Service Organizations Letter [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Burgess - Mobile Instrument Service and Repair, Inc. Letter [PDF] Added 05/19/2017 at 05:17 PM
  • Document for the Record - Rep. Burgess - AARP Statement [PDF] Added 05/19/2017 at 05:17 PM

Member Statements

  • Opening Statement - Full Committee Chairman Greg Walden [PDF] Added 05/02/2017 at 06:12 PM
  • Opening Statement - Health Subcommittee Chairman Michael C. Burgess [PDF] Added 05/02/2017 at 06:12 PM
  • Opening Statement - Full Committee Ranking Member Pallone [PDF] Added 05/19/2017 at 05:17 PM

Hearing Record

  • Hearing Attendance [PDF] Added 05/02/2017 at 06:12 PM
  • Preliminary Transcript [PDF] Added 05/10/2017 at 02:00 PM

First Published: April 25, 2017 at 03:08 PM
Last Updated: May 19, 2017 at 05:17 PM


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