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HR 1463119th CongressIn Committee

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.

Introduced: Feb 21, 2025
Standard Summary
Comprehensive overview in 1-2 paragraphs

H.R. 1463 would block the use of any Federal funds to implement, administer, or enforce the Food and Drug Administration’s final rule about Medical Devices; Laboratory Developed Tests (LDTs). The specified rule is the FDA final rule submitted for publication in the Federal Register on May 6, 2024 (89 Fed. Reg. 37286), and the bill also bars funding for any substantially similar rule. In other words, even if the FDA issues or enforces a rule regulating LDTs as medical devices, this bill would prohibit federal dollars from being used to carry out or enforce that rule. The bill was introduced in the House on February 21, 2025, by Rep. Finstad (with Rep. Crenshaw as a co-sponsor) and referred to the Committee on Energy and Commerce. What this means in practice is that the federal government would be barred from funding the actions needed to implement or enforce the FDA’s LDT rule. The bill does not repeal the rule itself; it restricts the use of federal money to put the rule into effect.

Key Points

  • 1Prohibits the use of Federal funds to implement, administer, or enforce the FDA final rule on Medical Devices; Laboratory Developed Tests (LDTs).
  • 2Applies to the rule as published in the Federal Register on May 6, 2024 (89 Fed. Reg. 37286) and to any substantially similar rule.
  • 3Uses a broad “Notwithstanding any other provision of law” clause, meaning the funding prohibition takes precedence over other laws or funding provisions.
  • 4Covers all federal funding used to implement, administer, or enforce the rule (not just specific programs).
  • 5Status: Introduced in the House (H.R. 1463) on February 21, 2025; referred to the Committee on Energy and Commerce.

Impact Areas

Primary group/area affected- Federal agencies involved in implementing or enforcing FDA regulatory actions on LDTs (primarily the FDA and any partner agencies administering related activities).- Laboratories that develop or perform Laboratory Developed Tests (LDTs), as the regulatory oversight would affect how LDTs are regulated and overseen.Secondary group/area affected- Healthcare providers and patients relying on or using LDTs, who could be affected by changes in regulatory oversight or clarity about test quality and safety.- Diagnostic test developers and clinical laboratories operating under or planning LDT workflows.Additional impacts- Federal funding and appropriations: The bill would constrain the ability of the FDA to fund the implementation or enforcement of the LDT rule, potentially leaving gaps in regulatory oversight for LDTs as outlined in the 2024 rule.- Regulatory certainty and public health oversight: If funding is blocked, there could be ambiguity or delays in implementing safety, quality, and oversight measures associated with LDTs.- Legislative landscape: This is part of an ongoing policy debate over FDA authority over LDTs; passage would represent a shift in how LDTs are regulated at the federal level.LDTs are diagnostic tests designed, developed, and used within a single laboratory, rather than mass-produced and sold as a kit. The FDA’s 2024 rule aimed to regulate LDTs more as medical devices; supporters argue it would improve test safety and reliability, while opponents contend it could constrain innovation and access.The bill has been introduced and referred to committee; it has not become law.
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