1. FY 2018 medical device user fee small business qualification and certification: guidance for industry, Food and Drug Administration staff and foreign governments Publication: Silver Spring, MD : Center for Devices and Radiological Health, August 29, 2017 Subject(s): Device ApprovalSmall BusinessEligibility DeterminationTaxesHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.