Bearing the Burden of "Innovation": The Ontological Implications of Substantial Equivalence and the FDA 510(K) Pathway.
作者信息
Maldonado Fabien, Eberl Jason
机构信息
Vanderbilt Center for Bioethics and Society and Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt School of Medicine, Nashville, TN.
Albert Gnaegi Center for Health Care Ethics, Saint Louis University, St. Louis, MO.
出版信息
Chest. 2023 May;163(5):1225-1227. doi: 10.1016/j.chest.2022.12.014.
PMID:37164576
Abstract
摘要
Zotero 插件