Research assistant for the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics of Harvard Medical School and Brigham and Women's Hospital in Boston, Massachusetts.
Professor of medicine at Harvard Medical School and the director of the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics of Harvard Medical School and Brigham and Women's Hospital in Boston, Massachusetts.
AMA J Ethics. 2021 Sep 1;23(9):E673-678. doi: 10.1001/amajethics.2021.673.
The number of new medical devices cleared by the US Food and Drug Administration (FDA) through the 510(k) pathway that has subsequently been associated with safety risks has led to discussion of approaches to regulation and communication of device risks. As debate continues over whether the pathway needs to be altered, features of ethical use of 510(k)-cleared devices can include (1) heightened caution with respect to newly cleared 510(k) products until adequate data are gathered through postmarket surveillance, (2) facilitating informed consent by improving physician and patient knowledge of the 510(k) pathway, and (3) basing distribution of these devices on individual risk assessments while ensuring equitable access.
美国食品和药物管理局 (FDA) 通过 510(k) 途径批准的新医疗器械数量不断增加，这些医疗器械随后与安全风险相关，这引发了对监管方法和器械风险沟通的讨论。随着关于该途径是否需要改变的争论仍在继续，510(k) 批准器械的伦理使用特征包括：(1) 在通过上市后监测收集到足够数据之前，对新批准的 510(k) 产品保持高度谨慎；(2) 通过提高医生和患者对 510(k) 途径的了解来促进知情同意；(3) 根据个体风险评估分配这些器械，同时确保公平获得。
