119th Congress · HOUSE BILLBILL

H.R. 1463To 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.

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.

Health
Introduced Feb 21, 2025
Last action Feb 21, 2025
Pipeline · Bill → Law
Step 1
Introduced
Feb 21, 2025
Step 2
Referred
Feb 21, 2025
E&C
Step 3
Committee
Step 4
House floor
Step 5
Senate
Step 6
Resolve Changes
Step 7
Signed
SummaryCRS Summary

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.

Provisions · 1 sectionsIntroduced in House
AI
Timeline · 2 actions
Feb 21, 2025
Introduced in House
Feb 21, 2025
Referred to the House Committee on Energy and Commerce.