Postmarket Requirements for Significant Risk Devices

The Food and Drug Administration (FDA) has developed multiple interrelated mechanisms for monitoring, evaluating, and taking remedial action (when necessary) against medical devices after they have gone to market. This chapter provides an overview of the various postmarket requirements that can be imposed on manufacturers, importers, distributors, and device-user facilities. 1 These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.