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# Hill Moves to Repeal FDA Rule on LDTs
- URL: https://www.fdaweb.com/hill-moves-to-repeal-fda-rule-on-ldts/
- Published: 2024-05-21T12:00:00.000Z
- Updated: 2026-09-14T14:31:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157029

Sen. **Rand Paul** (R-KY) and Rep. **Brad Finstad** (R-MN) have introduced resolutions in the Senate and House under the Congressional Review Act to repeal an FDA rule that asserts the agency’s authority to oversee laboratory-developed tests (LDTs). In a [statement](https://www.paul.senate.gov/dr-paul-rep-finstad-introduce-resolution-to-repeal-harmful-fda-rule-limiting-access-to-laboratory-developed-tests/?ref=fdaweb.com), Paul says the FDA rule “seeks to impose burdensome regulations on the creation and implementation of LDTs, limiting patients’ access to critical diagnostic testing.”

Paul and Finstad say implementation of the FDA rule would:

- delay or deprive patient access to tests that diagnose or indicate whether a patient is genetically predisposed to cancer, heart disease, or other conditions;
- impede collaborative efforts in clinical care that rely on the flexibility provided by lab tests; and
- limit the test offerings made available to patients because the economic burden imposed by the rule may force small and medium-sized laboratories to close.

“This is yet another brazen power grab by FDA under **President Biden**,” Paul said. “Unnecessary regulations on lab-developed tests threaten to delay critical diagnostics and undermine healthcare innovation. This CRA is a step towards preserving the innovation and flexibility needed to address emerging medical challenges and safeguard patient health.”