A joint resolution 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".

Bill 118 SJRes 82 is a joint resolution in the US Congress that aims to disapprove of a rule submitted by the Food and Drug Administration (FDA) regarding "Medical Devices; Laboratory Developed Tests." The resolution falls under chapter 8 of title 5 of the United States Code, which allows Congress to review and potentially overturn regulations proposed by federal agencies.

The rule in question pertains to laboratory developed tests (LDTs), which are medical tests developed and performed within a single laboratory. The FDA's rule seeks to regulate these tests to ensure their safety and effectiveness, similar to how other medical devices are regulated by the agency.

Supporters of the resolution argue that the FDA's regulation of LDTs could stifle innovation and hinder patient access to potentially life-saving tests. They believe that the current regulatory framework for LDTs, which involves oversight by organizations like the Centers for Medicare and Medicaid Services (CMS) and the Clinical Laboratory Improvement Amendments (CLIA), is sufficient to ensure the quality of these tests. Opponents of the resolution, on the other hand, argue that the FDA's oversight of LDTs is necessary to protect patients from potentially harmful or inaccurate tests. They believe that the FDA's expertise in regulating medical devices makes it the most appropriate agency to oversee LDTs and ensure their safety and effectiveness. The resolution is currently being debated in Congress, with lawmakers on both sides of the issue presenting their arguments. It remains to be seen whether the resolution will ultimately be passed and the FDA's rule on LDTs will be overturned.