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Presentation Outline. Presentation Outline. FDA OverviewDevice Classifications / Submission TypesApproval / Clearance RequirementsInvestigational DevicesCombination Products. . . . FDA Structure / Organization. Center for Veterinary Devices. Food and Drug Administration. Center for Biologics
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1. Understanding the Regulatory Landscape. MassMEDIC: Regulatory Boot Camp December 13, 2007