McGuireWoods’ Samuel C. Bernstein, Royce B. DuBiner and Allyson M. Maur discuss the impact of the FDA’s final rule on laboratory developed tests (LDTs). The trio discuss the FDA’s amendment to its regulation of in vitro diagnostic products (IVDs), including implications for LDTs on the market and whether alternative pathways may be available before the end of the FDA’s four-year phaseout of enforcement discretion. They also discuss how laboratories should plan for the rolling implementation of FDA requirements for LDTs, including complying with medical device reporting requirements, registration, listing, premarket review and other quality system requirements.
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