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HR 1463 119th Congress House Health 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

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.

Introduced: February 21, 2025 Introduced by: Finstad, Brad Republican · Minnesota See on congress.gov
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Feb 21, 2025
Referred to the House Committee on Energy and Commerce.
Feb 21, 2025
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now February 21, 2025

Referred to the House Committee on Energy and Commerce.

 Committees of jurisdiction 1