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

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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.

About the Author

Omar Ford

Omar Ford is a veteran reporter in the field of medical technology and healthcare journalism. As Editor-in-Chief of MD+DI (Medical Device and Diagnostics Industry), a leading publication in the industry, Ford has established himself as an authoritative voice and a trusted source of information.

Ford, who has a bachelor's degree in print journalism from the University of South Carolina, has dedicated his career to reporting on the latest advancements and trends in the medical device and diagnostic sector.

During his tenure at MD+DI, Ford has covered a wide range of topics, including emerging medical technologies, regulatory developments, market trends, and the rise of artificial intelligence. He has interviewed influential leaders and key opinion leaders in the field, providing readers with valuable perspectives and expert analysis.

 

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