Legislation Introduced to Reverse FDA Final Rule on LDTs

Legislators and pathologists alike are expressing opposition to the final rule from the U.S. Food and Drug Administration regulating laboratory-developed tests (LDTs) as medical devices.

On Feb. 21, U.S. Reps. Brad Finstad (R-Minn.) and Dan Crenshaw (R-Texas) introduced legislation that would effectively reverse the final rule. The Freedom for Laboratory Innovation and Testing Act would prohibit the use of federal funding to implement and enforce the LDT final rule.

Finstad and Crenshaw also cosigned a letter to U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., calling for the rule to be revoked, “allowing Congress to examine the issue and determine any necessary regulatory changes.”

The Association for Molecular Pathology, a plaintiff in the pending lawsuit against the FDA over the rule, is listed among the organizations that support the legislation. Meanwhile, the College of American Pathologists (CAP) on Feb. 14 sent a letter to Kennedy urging the administration to terminate the LDT rule in keeping with the executive order “Unleashing Prosperity Through Deregulation,” signed by the president on Jan. 31. The CAP is requesting HHS works with Congress to enact legislation that establishes a regulatory framework specifically for LDTs.

Sources:

https://finstad.house.gov/2025/2/reps-finstad-crenshaw-introduce-legislation-to-protect-lifesaving-diagnostic-testing-from-fda-overregulation

https://finstad.house.gov/_cache/files/6/9/69c84359-1893-4d55-8068-85d470b39142/B0BA6C3B9F808F9015F1213B30DDD9B2.letter-to-secretary-kennedy-to-revoke-the-fda-s-rule-on-ldts.pdf

https://newsroom.cap.org/latest-news/cap-urges-hhs-to-heed-executive-order-and-revoke-fda-ldt-regulation/s/51fe11f5-0ccd-4b4b-aad4-c9be890a4ab7

https://documents.cap.org/documents/CAP_letter_Kennedy_Confirmation_FNL_2025.pdf