New from the Diagnosing Health Care Podcast: Laboratories in the United States are facing a major regulatory landscape shift.
The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory developed tests (LDTs). What does this mean for labs going forward?
On this episode, Epstein Becker Green attorneys James Boiani, Rob Wanerman, and Megan Robertson lay out the new landscape, analyze existing and potential challenges, and identify key developments to watch for as this new regulatory era unfolds.
As of Monday March 4, 2024—just three months after the end of its comment period on December 4, 2023—FDA’s rule on regulation of laboratory developed tests (“LDTs”) as medical devices is under review by the Office of Information and Regulatory Affairs (“OIRA”) within the Office of Management and Budget (“OMB”). While review by OIRA is capped at 90 days by Executive Order 12866, there is no minimum period required, and therefore action can be taken any time between now and June.
During this election year, FDA’s efforts to push the rule forward fairly quickly is ...
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