In 2024 the U.S. Food and Drug Administration plans to regulate laboratory-developed tests, clarify guidelines for medical devices and artificial intelligence, and act on drug shortages, among other actions.
The FDA is reviewing a proposal to regulate laboratory-developed tests as medical devices under the Federal Food, Drug, and Cosmetic Act. This regulation could trigger substantial litigation, as critics argue the agency doesn’t have the authority to regulate LDTs.
In a Bloomberg Law article, life sciences regulatory and compliance partner Joshua Oyster notes that it is possible the U.S. Congress is rejuvenated in 2024 to discuss legislation related to LDT reform, but this may be impacted by the upcoming elections.Stay Up To Date with Ropes & Gray
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