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- Title
Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011.
- Authors
Rathi, Vinay K.; Krumholz, Harlan M.; Masoudi, Frederick A.; Ross, Joseph S.
- Abstract
This cross-sectional study provides a 5-year update on the status and availability of postmarket evidence for high-risk medical devices that received FDA premarket approval in 2010 and 2011.
- Subjects
COMMERCIAL product evaluation; MEDICAL equipment; UNITED States. Food & Drug Administration; NEW product development laws; MEDICAL equipment safety measures; EQUIPMENT & supplies; CROSS-sectional method; DATA analysis software; DESCRIPTIVE statistics
- Publication
JAMA Network Open, 2020, Vol 3, Issue 8, pe2014496
- ISSN
2574-3805
- Publication type
Academic Journal
- DOI
10.1001/jamanetworkopen.2020.14496