1. Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff : guidance for industry and Food and Drug Administration staff Publication: [Silver Spring, Maryland] : Center for Devices and Radiological Health, September 29, 2017 Subject(s): Device Approval -- standardsClinical ProtocolsResearch DesignTelecommunicationsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.