NYSCLA Alert to Laboratories (September 2024)

FDA’s Final Rule Regulating LDTs

Tuesday, September 3, 2024 (Last updated: Aug 6 2026 21:56)

On May 6, 2024, the Food and Drug Administration (“FDA”) issued its long-anticipated final rule regulating laboratory developed tests (“LDTs”). In the May 6, 2024 final rule, the FDA outlined several categories of full and partial enforcement discretion, as described in more detail below.

The FDA’s final rule subjects substantially all LDTs to FDA regulation. However, the FDA, in the commentary to the final rule, outline its intent to exercise enforcement discretion over a four-year phase-out period, and not subject certain categories of enforcement discretion to the entire set of FDA regulatory requirements that would otherwise be applicable to medical devices.

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