CDRH Industry: Medical Device Tracking - Guidance for Industry and FDA Staff

The Food and Drug Administration (FDA) is issuing this guidance to announce that both the list of devices subject to medical device tracking requirements, and the list of medical devices released from tracking requirements, have been updated.  This updated guidance identifies all affected devices (those tracked and those released from tracking) in table format. The table includes two fields to describe each device: (1) product code (procode) and (2) the standardized procode definition (product code – preferred term). These two descriptive fields are intended to provide clarity about which devices are tracked. The product code and preferred name are generally found in the approval or clearance letter issued by CDRH. For more information, please see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071756.htm


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