Researchers Question Efficacy Of FDA’s Device Surveillance System
Executive Summary
Recent medical journal papers call into question the effectiveness of the US agency’s medical device surveillance system, arguing that it’s too slow to pick up on safety signals.
You may also be interested in...
New Safety Framework Mixes Current Efforts, New Investments At US FDA
In a new "action plan," FDA is stitching together a plethora of ongoing and proposed initiatives to help spur product safety and quality efforts through increased regulatory authority and more incentives for device-makers.
St Jude's Riata recall gets most serious classification from FDA
The US FDA has classified as a Class I recall St Jude Medical's warning to doctors about the higher-than-thought failure rates of its silicone-insulated Riata defibrillator leads.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.