From Discretion to Regulation: What FDA’s Final Rule Means for Laboratory Developed Tests

Lexology June 5, 2024
Hall Render Killian Heath & Lyman PC

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. § 809.3. The Final Rule completely changed the regulatory status of Laboratory Developed Tests (“LDTs”) by adding the following additional language: “including when the manufacturer of these products is a laboratory.” With this seemingly simple change, the FDA has asserted jurisdiction over LDTs, making them subject to the FDA’s oversight under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), implementing regulations and ending the FDA’s general enforcement discretion approach for LDTs. The Final Rule is set to take effect on July 5, 2024.

The Final Rule, at over 150 pages in length, expands...

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