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.
Beatrice L. Brown joins Ethics Talk to discuss her article, coauthored with Dr Aaron S Kesselheim: "How Should Clinicians and Organizations Assess Risks and Benefits of First-in-Human Implantation of Investigational Devices?"
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?"