Bill Details
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AI Summary This summary was generated by AI from the bill text. AI can get information wrong.
This bill would stop federal money from being used to carry out, manage, or enforce a Food and Drug Administration rule about laboratory developed tests. In simple terms, it would block the FDA from using federal funds to put that rule into effect, and it would also apply to any similar rule in the future. The bill does not change the rule itself directly; instead, it limits funding for enforcing it.
- It targets an FDA final rule on “Medical Devices; Laboratory Developed Tests” that was submitted for publication on May 6, 2024.
- No federal funds could be used to implement, administer, or enforce that rule.
- The ban would also cover any substantially similar rule.
Official Summaries
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.
Current Full Text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1463 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 21, 2025
Mr. Finstad (for himself and Mr. Crenshaw) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. PROHIBITION ON FUNDING FOR FOOD AND DRUG ADMINISTRATION RULE
RELATING TO MEDICAL DEVICES; LABORATORY DEVELOPED TESTS.
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.
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