2010 年和 2011 年获得美国食品和药物管理局上市前批准的高风险治疗性医疗器械的上市后临床证据。
Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011.
机构信息
Department of Otolaryngology, Massachusetts Eye and Ear, Boston.
Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
出版信息
JAMA Netw Open. 2020 Aug 3;3(8):e2014496. doi: 10.1001/jamanetworkopen.2020.14496.
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.
摘要
本横断面研究提供了 2010 年和 2011 年获得美国食品和药物管理局（FDA）上市前批准的高风险医疗器械上市后证据的现状和可用性的 5 年更新。
Zotero 插件