FDA categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions: guidance for sponsors, clinical investigators, industry, institutional review boards, and Food and Drug Administration staff FDA categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions: guidance for sponsors, clinical investigators, industry, institutional review boards, and Food and Drug Administration staff

Collection: Health Policy and Services Research Series Title(s): Guidance for industry Contributor(s): United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Publication: Silver Spring, MD : Center for Devices and Radiological Health, December 5, 2017 Language(s): English Format: Text Subject(s): Device Approval Equipment and Supplies Insurance Coverage Medicare -- economics Therapies, Investigational United States United States. Department of Health and Human Services United States. Food and Drug Administration Centers for Medicare & Medicaid Services (U.S.) Genre(s): Guideline Technical Report Copyright: The National Library of Medicine believes this item to be in the public domain. (More information) Extent: 1 online resource (1 PDF file (14 pages)) Illustrations: Illustrations NLM Unique ID: 101719990 (See catalog record) Permanent Link: http://resource.nlm.nih.gov/101719990