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
- Response to Questions for the Record
[PDF]
Added
06/02/2016 at 02:23 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:
June 2, 2016 at 02:23 PM