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>
Introduced:
Feb 21, 2025
Policy Area:
Health
Congress.gov:
Bill Statistics
3
Actions
7
Cosponsors
1
Summaries
6
Subjects
1
Text Versions
Yes
Full Text
AI Summary
AI Summary
No AI Summary Available
Click the button above to generate an AI-powered summary of this bill using Claude.
The summary will analyze the bill's key provisions, impact, and implementation details.
Error generating summary
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. </p><p>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.</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
Cosponsors (7)
(R-TX)
Aug 8, 2025
Aug 8, 2025
(R-KY)
Apr 1, 2025
Apr 1, 2025
(R-FL)
Mar 21, 2025
Mar 21, 2025
(R-TX)
Mar 4, 2025
Mar 4, 2025
(R-TX)
Feb 27, 2025
Feb 27, 2025
(R-IA)
Feb 24, 2025
Feb 24, 2025
(R-TX)
Feb 21, 2025
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,
[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.