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May 06, 2024   

The End of an Era? FDA Finalizes LDT Rule but Grandfathers Many Existing LDTs

This Briefing is brought to you by AHLA’s Life Sciences Practice Group.
  • May 06, 2024
  • Danielle Sloane , Bass Berry & Sims PLC
  • Heather Pearson , Bass Berry & Sims PLC

On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of LDTs as medical devices. The agency’s final rule amends the definition of in vitro diagnostics (IVDs) at 21 C.F.R. § 809.3(a) to clarify that IVDs, which include LDTs, are medical devices even if manufactured in a laboratory, and describes the agency’s stage-based approach to ending enforcement discretion over these products. However, the final rule also includes significant concessions to the industry as compared to the proposed rule.


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