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