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.
Referred to the House Committee on Energy and Commerce.
Congressional Research Service
Official summary
Version 00 · Introduced in House · Feb 21, 2025
This bill prohibits the use of federal funds to implement, administer, or enforce the final rule issued by the Food and Drug Administration (FDA) titled Medical Devices; Laboratory Developed Tests and published on May 6, 2024, or any substantially similar rule.
The rule specifies that laboratory developed tests (medical screening tests developed by laboratories rather than medical device manufacturers) are medical devices subject to FDA regulation with limited exceptions. Prior to the rule, the FDA had exercised discretion as to whether to apply regulations for medical devices to laboratory developed tests.
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Aug 9, 2025. Consult Congress.gov for the current record.
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PlainBill explanation
Read the proposal in plain language
AI-generated · Source-checked by AI · Nov 1, 2026
Based on the full Introduced in House · 2025-02-21 text. This explanation has not received human editorial review. This overview describes the proposal’s major provisions; it does not establish what its real-world effects would be.
What it would do
This bill would prevent federal money from being used to carry out or enforce a specified Food and Drug Administration rule concerning laboratory-developed tests, or any substantially similar rule. It proposes a funding restriction on federal regulatory activity; the supplied text does not establish that this restriction became law.
Check the sources
Notwithstanding any other provision of law, no Federal funds may be used to implement, administer, or enforce the final rule of the Food and Drug Administration relating to Medical Devices; Laboratory Developed Tests
The proposed prohibition would apply despite any other provision of law and would cover implementation, administration, and enforcement. It identifies the targeted rule by its May 6, 2024 submission for Federal Register publication and citation, 89 Fed. Reg. 37286, and extends the restriction to substantially similar rules.
Check the source
Notwithstanding any other provision of law, no Federal funds may be used to implement, administer, or enforce the final rule of the Food and Drug Administration relating to Medical Devices; Laboratory Developed Tests that was submitted for publication in the Federal Register on May 6, 2024 (89 Fed. Reg. 37286), or any substantially similar rule.
The supplied actions snapshot, updated August 9, 2025, records introduction in the House and referral to the House Committee on Energy and Commerce on February 21, 2025.
Check the source
Source snapshot updated 2025-08-09T08:05:49Z.
2025-02-21: Referred to the House Committee on Energy and Commerce.
2025-02-21: Introduced in House
Reviewed version: Introduced in House · 2025-02-21. These findings describe provisions and who may benefit; they are not judgments of waste, corruption, or motive.
This review covers the supplied bill text. “None identified” does not rule out provisions in later versions or accompanying reports and disclosures.
Provisions outside the bill’s main subject, or policy changes attached to appropriations.
None identified in the reviewed text
No unrelated provision was identified in the complete supplied introduced text. This conclusion is limited to that version and does not establish absence in other versions or accompanying materials.
Spending directed to particular recipients or places outside ordinary competitive or formula-based allocation.
None identified in the reviewed text
No congressionally directed spending for particular recipients or places was identified in the complete supplied introduced text. This conclusion is limited to that version; earmark disclosures and accompanying committee materials were not supplied.
Other targeted benefits
Narrow exceptions, exemptions, or preferential treatment that warrant a closer look.
None identified in the reviewed text
No separate narrow carve-out, special exemption, or preferential treatment was identified in the complete supplied introduced text. This conclusion is limited to that version and does not establish absence in other versions or accompanying materials.
What this analysis cannot establish
The referenced FDA rule is not supplied, so its requirements, coverage, and practical consequences cannot be determined from this bundle.
The bill does not define “substantially similar” or specify an implementation date, expiration date, exceptions, or a separate enforcement mechanism.
The supplied history does not establish legislative developments after the dated snapshot or whether the proposal became law. Missing actions do not prove that it never advanced or was never enacted.
Full text preserved for this analysis. Legislative record snapshot: Aug 9, 2025. How PlainBill uses AI