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.
The AMA’s Historic Health Fraud and Alternative Medicine Collection includes images of quack devices from the early 20th century that generated oversight we now take for granted.
AMA J Ethics. 2021;23(9):E721-738. doi:
10.1001/amajethics.2021.721.
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 Donna-Bea Tillman joins Ethics Talk to discuss her article: "What Should the Public Know About Implantable Material and Device Innovation in the US?"
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?"