ARTICLE SUMMARY:
The agency has issued final guidance on allowing unauthorized diagnostics in a federally declared emergency. Excerpted from Pathways’ Picks September 24: Breakthrough Bill Optimism, EU Reform Talk, Malaysia Joins MDSAP.
FDA finalized guidance this week on when it might allow unauthorized diagnostics on the market in the context of a federally declared emergency. The guide, updated from a 2024 draft, specifically addresses the factors the agency will consider for beginning and ending “enforcement policies” during a Section 564 declared emergency. Such enforcement policies, such as approaches adopted during COVID-19, could lay out stipulations for companies to roll out certain tests that have been validated but have yet to receive an FDA emergency use authorization. The final guidance adds the phrase “begin and end” to underscore that that agency will user the factors as a basis for issuing an enforcement policy and determining when the policy is no longer needed. FDA also tweaks the focus of the final guidance from “tests” to “in vitro diagnostic tests,” emphasizing that it no longer has authority over laboratory developed test (LDT) services, even in an emergency. FDA officially rescinded its 2024 regulation defining its authority to regulate laboratory developed test services produced and performed in a single lab. The September 18 “Implementation of vacatur” notice was the final step in the agency’s retreat from the LDT space following the March federal court ruling to vacate the LDT regulation and FDA’s subsequent decision not to appeal.