Bearing the Burden of "Innovation": The Ontological Implications of Substantial Equivalence and the FDA 510(K) Pathway

Chest. 2023 May;163(5):1225-1227. doi: 10.1016/j.chest.2022.12.014.

Authors

Fabien Maldonado¹, Jason Eberl²

Affiliations

¹ Vanderbilt Center for Bioethics and Society and Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt School of Medicine, Nashville, TN. Electronic address: fabien.maldonado@vumc.org.
² Albert Gnaegi Center for Health Care Ethics, Saint Louis University, St. Louis, MO.

PMID: 37164576
DOI: 10.1016/j.chest.2022.12.014

No abstract available

Publication types

Editorial

MeSH terms

Device Approval*
Humans
United States
United States Food and Drug Administration