What This Bill Does · Plain English
Summary · Congress.gov
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.
Action Timeline
2025-02-21
Referred to the House Committee on Energy and Commerce.
2025-02-21
Introduced in House
2025-02-21
Introduced in House
Frequently Asked Questions
Did HR.1463 pass?
HR.1463 is still alive. Current stage: COMMITTEE. Pass likelihood: 43%.
What does HR.1463 do?
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 de…
Who sponsored HR.1463?
HR.1463 was sponsored by Brad Finstad (R-Minnesota).
Full Bill Text
119 HR 1463 IH: 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. U.S. House of Representatives 2025-02-21 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. 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.
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