Billing Beat

No Appeal of FDA/LDT Lawsuit Decision

May 31, 2025

On Saturday, May 31, 2025, the appeal window closed in the of ACLA v. FDA lawsuit without the government filing an appeal.

Therefore, the Texas District Court’s decision to vacate, in its entirety, the FDA’s attempt to regulate Laboratory Developed Tests (LDTs) as medical devices stands.

Source: https://www.nila-usa.org/NewsBot.asp?MODE=VIEW&ID=1144

LDT Regulatory Laboratory

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