Hearing: Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule

Subcommittee on Health (Committee on Energy and Commerce)

Thursday, March 21, 2024 (10:00 AM)

2123 RHOB
Washington, D.C.

Witnesses

Ms. Susan Van Meter
President, American Clinical Laboratory Association (ACLA)

Added 03/19/2024 at 11:25 AM
  • Witness Statement [PDF] Added 03/19/2024 at 11:41 AM
  • Questions For the Record Transmittal Letter [PDF] Added 05/08/2024 at 03:50 PM
  • Responses to Questions For the Record [PDF] Added 05/21/2024 at 05:40 PM
  • Witness Truth in Testimony [PDF] Added 03/19/2024 at 11:41 AM
  • Witness Biography [PDF] Added 03/19/2024 at 11:41 AM

Mr. Zach Rothstein, JD
Executive Director, AdvaMedDx

Added 03/19/2024 at 11:25 AM
  • Witness Statement [PDF] Added 03/19/2024 at 11:41 AM
  • Questions For the Record Transmittal Letter [PDF] Added 05/08/2024 at 03:50 PM
  • Responses to Questions For the Record [PDF] Added 05/21/2024 at 05:40 PM
  • Witness Truth in Testimony [PDF] Added 03/19/2024 at 11:41 AM
  • Witness Biography [PDF] Added 03/19/2024 at 11:41 AM
  • Curriculum Vitae [PDF] Added 03/19/2024 at 11:41 AM

Dr. Donald S. Karcher, MD, FCAP
President, College of American Pathologists (CAP)

Added 03/19/2024 at 11:25 AM
  • Witness Statement [PDF] Added 03/19/2024 at 11:41 AM
  • Questions For the Record Transmittal Letter [PDF] Added 05/08/2024 at 03:50 PM
  • Witness Truth in Testimony [PDF] Added 03/19/2024 at 11:41 AM
  • Curriculum Vitae [PDF] Added 03/19/2024 at 11:41 AM

Dr. Jeff Allen, PhD
President and CEO, Friends of Cancer Research

Added 03/19/2024 at 11:25 AM
  • Witness Statement (Update #2) [PDF] Added 03/19/2024 at 01:58 PM
  • Questions For the Record Transmittal Letter [PDF] Added 05/08/2024 at 03:50 PM
  • Responses to Questions For the Record [PDF] Added 05/21/2024 at 05:40 PM
  • Witness Truth in Testimony [PDF] Added 03/19/2024 at 01:58 PM
  • Curriculum Vitae [PDF] Added 03/19/2024 at 01:58 PM
  • Witness Biography [PDF] Added 03/19/2024 at 04:35 PM

Dr. Dara L. Aisner, MD, PhD
Medical Director, Colorado Molecular Correlates Laboratory, Professor of Pathology, University of Colorado, Representative of the Academic Coalition for Effective Laboratory Developed Tests

Added 03/19/2024 at 11:25 AM
  • Witness Statement [PDF] Added 03/19/2024 at 01:58 PM
  • Questions For the Record Transmittal Letter [PDF] Added 05/08/2024 at 03:50 PM
  • Witness Truth in Testimony [PDF] Added 03/19/2024 at 01:58 PM
  • Curriculum Vitae [PDF] Added 03/19/2024 at 01:58 PM

Support Documents

  • Hearing Notice [PDF]
  • Public Memo [PDF] Added 03/19/2024 at 11:25 AM
  • Documents For the Record [PDF] Added 03/25/2024 at 10:02 PM

Member Statements

  • The Honorable Brett Guthrie Opening Statement [PDF] Added 03/25/2024 at 05:18 PM
  • The Honorable Cathy McMorris Rodgers Opening Statement [PDF] Added 03/25/2024 at 05:18 PM
  • The Honorable Anna Eshoo Opening Statement [PDF] Added 03/25/2024 at 05:18 PM
  • The Honorable Frank Pallone, Jr. Opening Statement [PDF] Added 03/25/2024 at 05:18 PM

Hearing Record

  • Member Attendance [PDF] Added 03/25/2024 at 08:38 PM
  • Unedited Hearing Transcript [PDF] Added 06/07/2024 at 12:11 PM

First Published: March 15, 2024 at 10:12 AM
Last Updated: June 26, 2024 at 11:10 AM