FDA strikes the LDT rule from the CFR after losing in court

MedDevice Startups Staff · Sep 19 · 2 min read · Via Federal Register notice

FDA on September 19, 2025 published a final rule deleting the phrase it added to 21 CFR 809.3(a) in May 2024. That phrase declared in vitro diagnostic products to be devices "including when the manufacturer of these products is a laboratory." The deletion took effect the same day. FDA called the action ministerial. It implements the March 31, 2025 order in American Clinical Laboratory Association v. FDA (No. 4:24-CV-479, E.D. Tex.), which vacated the rule in full. The agency let the appeal window close in June.

For a diagnostics startup, the result is the market that existed before 2024. A test developed and run inside one CLIA-certified laboratory stays under CMS oversight through CLIA, with FDA generally exercising enforcement discretion. A kit, reagent or software product sold to other labs is a device and needs a 510(k), De Novo or PMA. The first phase-in obligations under the 2024 rule, which had been due May 6, 2025, never took effect.

The rescission removes a compliance deadline, not the commercial question behind it. Hospital buyers and payers still ask what evidence sits behind a test, and an FDA authorization remains the cleanest answer.

Questions & Answers

What did FDA's September 19, 2025 final rule on laboratory developed tests do?

The September 19, 2025 final rule removed the language FDA added to 21 CFR 809.3(a) in May 2024 that treated laboratory-made IVDs as devices. It restored the regulation to its pre-2024 text, effective the same day.

Why did FDA rescind the laboratory developed test rule?

A federal court in the Eastern District of Texas vacated the LDT rule on March 31, 2025 in American Clinical Laboratory Association v. FDA. FDA did not appeal, and it described the September 2025 rule as a ministerial step to reflect the court's order.

Do laboratory developed tests need FDA clearance after the LDT rule was vacated?

A test developed and performed inside a single CLIA-certified laboratory returns to CMS oversight under CLIA, with FDA generally exercising enforcement discretion. Kits, reagents or software sold to other laboratories remain devices that need a 510(k), De Novo or PMA.

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