119-hr1463

HR
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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.

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Introduced:
Feb 21, 2025
Policy Area:
Health

Bill Statistics

3
Actions
7
Cosponsors
1
Summaries
6
Subjects
1
Text Versions
Yes
Full Text

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Latest Action

Feb 21, 2025
Referred to the House Committee on Energy and Commerce.

Summaries (1)

Introduced in House - Feb 21, 2025 00
<p>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 <em>Medical Devices; Laboratory Developed Tests</em> and published on May 6, 2024, or any substantially similar rule.&nbsp;</p><p>The rule specifies that laboratory developed tests&nbsp;(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.</p>

Actions (3)

Referred to the House Committee on Energy and Commerce.
Type: IntroReferral | Source: House floor actions | Code: H11100
Feb 21, 2025
Introduced in House
Type: IntroReferral | Source: Library of Congress | Code: Intro-H
Feb 21, 2025
Introduced in House
Type: IntroReferral | Source: Library of Congress | Code: 1000
Feb 21, 2025

Subjects (6)

Administrative law and regulatory procedures Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Health (Policy Area) Health programs administration and funding Medical tests and diagnostic methods

Text Versions (1)

Introduced in House

Feb 21, 2025

Full Bill Text

Length: 1,563 characters Version: Introduced in House Version Date: Feb 21, 2025 Last Updated: Nov 15, 2025 6:15 AM
[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.
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.
<all>