Devices subject to premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act (the Act) are subject to periodic reporting requirements set forth in the PMA approval order (21 CFR 814.82(a), 21 CFR 814.84(b)). This guidance document is intended to help ensure that annual reports are complete and that the actions of CDRH and CBER staff are consistent. It can be viewed at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089381.htm
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