MedTech Dive September 19, 2025
Regulation of lab developed tests returns to its status before the agency attempted to expand its jurisdiction and industry groups sued to stop it.
The Food and Drug Administration has rescinded its final rule on laboratory developed tests, formally ending a decades-long effort to expand oversight of the lab industry.
The FDA issued a new final rule, scheduled for publication Friday in the federal register, that changes the definition of in vitro diagnostics back to language that was in its regulations before the 2024 rule was enacted.
The amendment follows a federal district court order in March that vacated the controversial 2024 rule after lab industry groups sued to stop its implementation. The FDA declined to appeal the district court’s...
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