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.
Summary
H.R. 1463 would prohibit the use of federal funds to implement, administer, or enforce an FDA rule issued in May 2024 that classifies laboratory-developed tests as medical devices subject to FDA regulation. Laboratory-developed tests are medical screening tests created by laboratories rather than commercial medical device manufacturers. Prior to this rule, the FDA had discretion over whether to regulate these tests as medical devices.
If enacted, this bill would prevent federal funding from being used to carry out the FDA's oversight of laboratory-developed tests. This could affect how these tests are regulated and made available to patients and healthcare providers. The practical impact would depend on whether other funding sources could support the FDA's regulatory activities, and whether the agency could enforce the rule through alternative means. The bill is currently in committee and has not yet been voted on by the full House.