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 16, 2024
Referred to the House Committee on Energy and Commerce.
This joint resolution would reject a Food and Drug Administration rule issued in May 2024 that regulates laboratory-developed tests as medical devices. Laboratory-developed tests are diagnostic tests created and used by individual laboratories rather than manufactured by commercial companies. The resolution uses a congressional disapproval process under federal law that allows Congress to overturn regulatory actions without going through the standard legislative process. If approved, the FDA rule would be nullified and would not take effect. The resolution was introduced by Representatives Finstad and Crenshaw and does not include specific funding or implementation timelines since it functions as a veto of an existing regulation rather than creating a new program.
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