5 Things You Need to Know About FDA’s Final Rule on LDTs
A look at the five stages of FDA’s phaseout policy concerning laboratory-developed tests.
Omar Ford
May 10, 2024
5 Slides
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Image Credit: Ted Horowitz Photography/Getty Images
Late last month, FDA shook up the diagnostic industry by issuing a final rule for laboratory-developed tests. The updated regulations would classify LDTs as medical devices under the FD&C Act, impacting oversight.
Enforcement of the rule isn’t expected to happen overnight – and FDA plans a four-year phase-out enforcement discretion for LDTs. MD+DI has compiled a list of the phaseout plan from FDA's website.
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