Lexology October 3, 2023
On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate, Leading-edge IVCT Development Act (VALID), legislation endorsed by the agency that would have addressed the regulation of LDTs in the context of enacting comprehensive reform of in vitro diagnostics (IVD) regulation. Subsequently, FDA signaled an intention to address LDTs through notice and comment rulemaking, while continuing to voice support for comprehensive legislative reform.
Comments on the proposed rule are due 60 days after publication. It is widely anticipated that FDA will prioritize finalizing the rule next year, at which point it is likely to face one or more...
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