![]() FDA addresses those device types in another guidance entitled, "Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use" (BGMS guidance). This guidance is not meant to address blood glucose monitoring test systems which are intended for prescription point-of-care use in professional healthcare settings (e.g., hospitals, physician offices, long term care facilities). ![]() 1 This guidance document is intended to guide manufacturers in conducting appropriate performance studies and preparing 510(k) submissions for these device types and replaces the final guidance entitled "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" issued on October 11, 2016. This guidance document describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems (SMBGs) which are for over-the-counter (OTC) home use by lay-users. Center for Devices and Radiological Health
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