Manatt Health March 25, 2024
On March 21, 2024, the Health Subcommittee of the House Energy & Commerce Committee held a hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” In the wake of repeated congressional inaction on the Verifying Accurate Leading-edge IVCT Development Act or the “VALID Act” (S. 2209/H.R. 2369), which would establish a new regulatory framework for in vitro diagnostic (IVD) tests, FDA issued a Proposed Rule late last year that, if finalized, would phase out its long-standing enforcement discretion approach for so-called “laboratory developed tests” (LDT), subjecting them to the same enforcement approach as other IVDs. As noted by Ranking Member Anna Eshoo during the hearing, this is the “sixth year for Congress to...
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