A Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs
By EsqSocial Corporation 01/04/25
The order is in, and the LDT Final Rule is out. In May 2024, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published its Final Rule establishing its regulatory framework over laboratory developed tests (“LDTs”) as medical devices and, in effect, announced the end to decades of enforcement discretion by the Agency....
By: Epstein Becker & Green