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

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.

About the Author(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].


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