US FDA orders post-market surveillance for metal-on-metal hips
This article was originally published in RAJ Devices
Executive Summary
The US Food and Drug Administration has asked manufacturers of metal-on-metal hip implants to carry out post-market surveillance studies1. The FDA has issued a total of 145 orders for post-market studies to 21 manufacturers, who are now required to submit research protocols to the agency addressing specific safety issues relating to their devices.