1. Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, October 25, 2017 Subject(s): Device Approval -- standardsEquipment Design -- standardsEquipment Safety -- standardsProduct Labeling -- standardsReagent Kits, Diagnostic -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
