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.
Fabian von Knoch, MD, Anthony Marchie, MD, MPhil, and Henrik Malchau, MD, PhD
An argument that national joint registries have improved outcomes for arthroplasty patients because they track device performance, reduce revision surgeries, and promote evidence-based surgery.