H.R. 1463: 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.

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.

Written by the Congressional Research Service, Library of Congress.