14. Department of Health and Human Services · Minor · Needs Congress
Revise statutes and rules to ease access to laboratory-modified tests
Printed page 457 14. Department of Health and Human Services
“To avoid stifling innovation and access to medical care, the applicable statutes and regulations should be revised to facilitate greater access to such modified tests.”
What has happened
- Partially done
FDA revised the regulation that governed laboratory-modified tests. Its May 2024 rule had brought laboratory-developed and laboratory-modified tests inside the definition of "in vitro diagnostic products"; the Eastern District of Texas vacated that rule on 2025-03-31, and FDA's final rule of 2025-09-19 reverted 21 CFR 809.3(a) to its pre-2024 text rather than appealing or re-proposing. That delivers the regulatory half of the ask - access to modified tests is easier than the 2024 rule would have allowed. The statutory half is untouched: the VALID Act of 2025 (H.R. 3694, S. 1932, both introduced 2025-06-03) sits in committee.
Research log
What was searched, and what didn’t count as evidence
Research notes
- Executive action on an ask that needs an act of Congress is partial where it eliminates the regulation that embodies the burden, which is what the reversion does; the statute the Quote also names is unchanged.
- This item and #1226 and #1228 all sit on the same instrument. #1227 takes partial because its ask is literally that the regulations be revised; the other two ask for things the reversion does not supply.
- Action
- other
- Object
- statutes and regulations governing laboratory-modified tests
- ID
- 1227