Lexology November 29, 2023
The US Food and Drug Administration (FDA) is resolute in its quest to phase out its enforcement-discretion approach for laboratory-developed tests (LDTs). On October 3, 2023, FDA published a proposed rule to confirm that LDTs are devices under the Federal Food, Drug, and Cosmetic Act (FDCA) and to describe FDA’s phase-out policy.1 At the subsequent webinar on October 31, 2023, FDA reiterated its rationale for initiating this rulemaking and clarified certain issues. Despite FDA’s clarifications, uncertainty remains. This alert provides a brief background on LDTs, discusses the proposed rule, summarizes FDA’s recent clarifications and offers insights into the road ahead as FDA seeks to finalize the rule.2
Background on LDTs
FDA regulation defines in vitro diagnostic products (IVDs)3 but not...
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