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

Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011.

Rathi, Vinay K.; Krumholz, Harlan M.; Masoudi, Frederick A.; Ross, Joseph S.