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Digging Into The Debate On FDA's Proposed Lab Test Rule

Member Joanne Hawana, Of Counsel Benjamin Zegarelli, and Associate David Gilboa authored an article recently published in Law360 examining the debate on FDA’s proposed lab test rule. The proposed rule makes an amendment to a single provision of FDA’s extensive regulations pertaining to medical devices, and, if finalized, would classify all laboratory developed tests into the definition of “in vitro diagnostic products” known as LDTs. 

The authors wrote, “If finalized and adopted, the FDA’s proposed rule will have a major impact on the future of LDT regulation and clinical use, with implications for both patient care and the diagnostic industry.”