Food and Drug Administration Regulation of in Vitro Diagnostic Devices

摘要: The Food and Drug Administration regulates the sale distribution of laboratory devices under a statutory regulatory framework that is unfamiliar to most clinical scientists. In this article we briefly describe criteria are used classify review in vitro diagnostic devices. We discuss similarities differences between not subject premarket review, those required undergo either application or notification [510(k)] pathway. then methods uses assess performance marketplace as component total life cycle approach medical device regulation.