FDA’s moves towards regulating Lab Developed Tests (LDT) or reference labs, currently regulated under CLIA, is a chilling thought, and especially at a time when the FDA is famously underfunded and understaffed, barely able to keep up with its colossal workload. CLIA regulation has worked smoothly for decades, and there have been scant scandals or evidence of malfunction in the system. A really bad idea.
http://lnkd.in/Y93yRa
linkedin post 2022-06-29 05:12:48
Nigel Fleming
September 21, 2022