FDA finalizes long-awaited rule to bring lab tests under its purview
The FDA on Monday finalized a long-awaited rule that outlines how it will regulate laboratory-developed tests (LDTs) as medical devices, even though some critics say the FDA is overstepping its authority.
The agency said the rule is needed to more closely regulate LDTs for safety and accuracy, but groups representing labs have argued that having the FDA regulate tests could slow innovation and make it harder for patients to get care.
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