14. Department of Health and Human Services · Minor · Needs Congress
Disentangle FDA and CMS authority over medical tests
Printed page 457 14. Department of Health and Human Services
“Congress, the FDA, and the CMS need to clarify and disentangle overlapping authorities over tests to eliminate regulatory confusion.”
What has happened
- Not started
Nobody disentangled FDA and CMS authority over tests. The VALID Act of 2025 - the bill that would draw the line - was introduced on 2025-06-03 as H.R. 3694 and S. 1932 and referred to committee, which is `not-started` on the Requires-Congress ladder. FDA's LDT rule was vacated and the pre-2024 text restored on 2025-09-19, which returns the two agencies to the overlapping arrangement the Quote complains about rather than clarifying it; no joint FDA-CMS policy statement was issued.
Research log
What was searched, and what didn’t count as evidence
Research notes
- Boundary call: a reviewer could read the vacatur as reducing the overlap (FDA steps back, CLIA and CMS keep the field) and call this partial. It is held at not started because a reversion by court order is not the clarification the Quote asks the three institutions to make.
- Action
- other
- Object
- overlapping FDA and CMS authority over medical tests
- ID
- 1228