A history of device oversight by the US Food and Drug Administration traces regulatory changes in response to injuries caused by Dalkon Shield intrauterine devices.
AMA J Ethics. 2021;23(9):E712-720. doi:
10.1001/amajethics.2021.712.
Charles E. Binkley, MD, Michael S. Politz, MA, and Brian P. Green, PhD
If the safe-and-effective standard for judging devices’ potential as therapy or enhancement is inadequate, one might wonder whether BCI regulation should be overseen by the FDA.
AMA J Ethics. 2021;23(9):E745-749. doi:
10.1001/amajethics.2021.745.
Dr Charles Binkley joins Ethics Talk to discuss his article, coauthored with Michael Politz and Dr Brian Green: "Who, If Not the FDA, Should Regulate Implantable Brain-Computer Interface Devices?"
Dr David Marcus joins Ethics Talk to discuss his article: “When, If Ever, Is It Appropriate to Regard a Patient as ‘Too Medically Complex’ for One Inpatient Service, But Not Another?”
Constraints on hospitalists and surgeons and restricted orthopedic admission criteria can exacerbate patients’ distress that comes from clinicians’ disagreements.
AMA J Ethics. 2023;25(12):E873-877. doi:
10.1001/amajethics.2023.873.