Food and Drug Administration. General shall retain records of the Study including either the original or a copy of all volunteer consent forms in conformance with applicable federal regulations. Company shall notify Principal Investigator of the date a premarket approval application (PMA) is approved for the Study Device; or if the application is not approved, Company shall notify Principal Investigator when all clinical investigations have been discontinued and the FDA notified.
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Samples: Clinical Trial Agreement (Laser Photonics Inc), Clinical Trial Agreement (Laser Photonics Inc), Clinical Trial Agreement (Laser Photonics Inc)
Food and Drug Administration. General shall retain records of the Study including either the original or a copy of all volunteer consent forms in conformance with applicable federal regulations. Company shall notify Principal Investigator of the date a premarket approval application (PMA) is approved for the Study DeviceDevices; or if the application is not approved, Company shall notify Principal Investigator when all clinical investigations have been discontinued and the FDA notified.
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