美国食品和药物管理局授权的 2015-2019 年高风险心血管器械上市后研究。
US Food and Drug Administration-Mandated Postmarketing Studies for High-risk Cardiovascular Devices Approved 2015-2019.
机构信息
University of Washington, Seattle.
Division of Cardiology, Department of Medicine, and Philip R. Lee Institute of Health Policy Studies, University of California, San Francisco.
出版信息
JAMA Intern Med. 2022 May 1;182(5):556-558. doi: 10.1001/jamainternmed.2022.0184.
Abstract
This qualitative study assesses the availability and strength of evidence of postapproval studies for high-risk cardiovascular devices subsequent to the 21st Century Cures Act.
摘要
本定性研究评估了 21 世纪治愈法案（21st Century Cures Act）后高风险心血管器械的上市后研究的可及性和证据强度。
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