Medical Devices — Balancing Regulation and Innovation

Abstract

Many Americans benefit from the implantation of medical devices, such as artificial joints and lifesaving defibrillators. Tragically, many also suffer or even die from complications related to medical devices that were never studied in clinical trials before being implanted in patients. As devices have evolved and become more complex, our device-approval system has become incapable of assuring safety and effectiveness. The system we use today was created 35 years ago in an era of much simpler and fewer devices, and it is now outdated. A recent, but not rare, example provides a cautionary tale about the challenges of ensuring that . . .