Zdrowie i gospodarka · 18/09/2020

FDA Proposes to Reclassify Cytomegalovirus DNA Quantitative Assay Devices for Transplant Patient Management

The US Food and Drug Administration (FDA) is proposing to reclassify cytomegalovirus (CMV) DNA quantitative assay devices intended for transplant patient management from a post-amendments class III device to a class II device, subject to premarket notification, in an effort to reduce regulatory burdens and provide a reasonable assurance of safety and effectiveness.