IN VITRO DIAGNOSTICS CENTER AT FDA URGED
This article was originally published in The Gray Sheet
Executive SummaryIN VITRO DIAGNOSTICS CENTER AT FDA URGED by the In-Vitro Diagnostics Manufacturers Coalition (IMC) in a position paper released at the Utah International Medical Device Congress held Aug. 18-19 in Salt Lake City. Arguing that IVDs "are mistakenly classified as medical devices," IMC maintains that the products "should be removed from the [Center for Devices and Radiological Health] and placed into a new regulatory center."
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