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