Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Food and Drug Administration relating to Medical Devices; Laboratory Developed Tests.
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Committee
Latest Action · May 15, 2024
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
This joint resolution would reject an FDA regulation governing laboratory-developed tests, which are medical tests created and used within individual laboratories rather than commercially produced devices. The resolution uses the Congressional Review Act, a procedure that allows Congress to overturn federal agency rules with a simple majority vote. If passed, the FDA's rule on laboratory-developed tests would be nullified and would have no legal effect. The measure affects diagnostic testing laboratories, healthcare providers, and patients who rely on these tests, as well as the FDA's regulatory authority over this sector. The resolution does not involve any funding or specify implementation timelines, as it simply seeks to disapprove an existing regulation.
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