5 Things You Need to Know About FDA’s Final Rule on LDTs

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.