Congress blocks FDA from regulating lab tests—no safety review required
H.R. 1463 — To prohibit the use of Federal funds to implement, administer, or enforce a final rule of the Food and Drug Administration relating to "Medical Devices; Laboratory Developed Tests", and for other purposes. · Filed by Brad Finstad (R-MN) · 7 cosponsors · Introduced Feb 21, 2025 · Referred to committee
Your members of Congress
Enter a ZIP to see where your representative and both senators stood on this bill.
Looked up on this device — your ZIP is never stored on our servers.
What it does
This bill blocks the FDA from spending any federal money to implement, administer, or enforce a new rule regulating laboratory-developed tests (LDTs)—medical tests designed and performed by individual labs rather than mass-produced devices. The rule, submitted in May 2024, would have brought LDTs under FDA oversight for the first time. By cutting off funding, the bill effectively prevents the FDA from enforcing the rule.
Why we flagged it
The bill's operative mechanism is a funding prohibition that prevents FDA enforcement of a specific rule. While framed as a narrow defunding measure, it functions as a de facto deregulation of laboratory-developed tests by removing the agency's ability to oversee them.
What the text implies
- The bill targets a rule that had not yet taken effect, suggesting it was introduced to preempt FDA authority before implementation began. This is a prospective defunding strategy, not a reversal of existing enforcement.
- Laboratory-developed tests are currently regulated under a 'enforcement discretion' framework—the FDA has largely not enforced device rules against LDTs. The May 2024 rule would have formalized FDA oversight. Blocking funding prevents a shift from informal to formal regulation.
The full analysis lists 4 implications of this text.
Who stands to gain
laboratory-developed test manufacturers; clinical laboratories; genetic testing companies