Meeting: Examining the Regulation of Diagnostic Tests and Laboratory Operations

Subcommittee on Health (Committee on Energy and Commerce)

Tuesday, November 17, 2015 (10:00 AM)

Meeting was rescheduled to the time and date listed above.
2322 RHOB
Washington, D.C.

Witnesses

Dr. Patrick Conway
Deputy Administrator for Innovation and Quality & Chief Medical Officer, Office of the Administrator, Centers for Medicare and Medicaid Services

Added 11/16/2015 at 09:41 AM
  • Witness Statement [PDF] Added 11/16/2015 at 09:41 AM
  • Questions for the Record [PDF] Added 12/07/2015 at 03:36 PM
  • Questions for the Record 2 [PDF] Added 05/23/2016 at 08:38 PM
  • Truth in Testimony and CV [PDF] Added 11/16/2015 at 09:51 AM

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

Added 11/16/2015 at 09:41 AM
  • Witness Statement [PDF] Added 11/16/2015 at 09:41 AM
  • Questions for the Record [PDF] Added 12/07/2015 at 03:36 PM
  • Questions for the Record 2 [PDF] Added 05/23/2016 at 08:38 PM
  • Truth in Testimony and CV [PDF] Added 11/16/2015 at 09:51 AM

Text of Legislation

  • H.R. ____, To establish a regulatory framework for in vitro clinical tests that advances innovation for patient benefit, protects patients, provides a predictable and timely path to market, ensures reasonable risk-based regulation, avoids duplicative regulation, advances precision medicine, and applies the same regulatory principles to the same activity regardless of entity type, and for other purposes. [PDF]

Support Documents

  • Hearing Notice [PDF] Added 10/22/2015 at 05:32 PM
  • Rescheduled Hearing Notice [PDF] Added 10/26/2015 at 03:40 PM
  • Rescheduled Hearing Notice 2 [PDF] Added 11/10/2015 at 03:27 PM
  • Background Memo [PDF] Added 11/13/2015 at 05:10 PM
  • Document for the Record - Rep. Burgess - AACC Letter [PDF] Added 11/17/2015 at 04:53 PM
  • Document for the Record - Rep. Burgess - AMP Letter [PDF] Added 11/17/2015 at 04:53 PM
  • Document for the Record - Rep. Collins - Rosewell Parks Letter [PDF] Added 11/17/2015 at 04:53 PM
  • Document for the Record - Rep. Green - ACS CAN Letter [PDF] Added 11/17/2015 at 04:53 PM
  • Document for the Record - Rep. Green - The Public Health Case for FDA Oversight of LDTs Report [PDF] Added 11/17/2015 at 04:53 PM
  • Document for the Record - Rep. Pitts - November 11 Letter [PDF] Added 11/17/2015 at 04:53 PM
  • Document for the Record - Rep. Pitts - November 16 Letter [PDF] Added 11/17/2015 at 04:53 PM
  • Opening Statement - Rep. Pitts [PDF] Added 11/17/2015 at 04:55 PM
  • Opening Statement - Rep. Upton [PDF] Added 11/17/2015 at 04:55 PM
  • Hearing Attendance [PDF] Added 11/17/2015 at 05:03 PM
  • Hearing Transcript [PDF] Added 11/24/2015 at 03:17 PM
  • Opening Statement - Rep. Ellmers [PDF] Added 12/07/2015 at 03:36 PM
  • Opening Statement - Rep. Pallone [PDF] Added 05/23/2016 at 08:38 PM
  • Opening Statement - Rep. Green [PDF] Added 05/23/2016 at 08:38 PM

First Published: October 22, 2015 at 04:54 PM
Last Updated: May 23, 2016 at 08:38 PM