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.

Bill: 119-hr-1463
Sponsor: full_name: Rep. Finstad, Brad [R-MN-1]
Introduced: 2025-02-21
Policy area: Health
Subjects: Administrative law and regulatory procedures

Drug safety, medical device, and laboratory regulation

Food and Drug Administration (FDA)

Health programs administration and funding

Medical tests and diagnostic methods
Latest action: action_date: 2025-02-21
text: Referred to the House Committee on Energy and Commerce.

Summaries:
action_date: 2025-02-21
action_desc: Introduced in House
text: <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>

tv_txt: I 119th CONGRESS 1st Session H. R. 1463 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.

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.