Healthy Skepticism Library item: 18855

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Avorn J.
Regulation of devices
BMJ 2010 Nov 2; 341:
http://www.bmj.com/content/341/bmj.c5730.extract

Abstract:

The development, approval, and surveillance of medical devices have some features in common with those for prescription drugs, as well as others that are even more challenging. Yet the regulatory traditions of the device world are strikingly different from those of drugs and often much more problematic. This is shown in the linked feature by Lenzer and Brownlee (doi:10.1136/bmj.c4753), which describes the history of a vagus nerve stimulator to treat epilepsy—a device with a worrying risk-benefit ratio⇓.1