FDA Targets Infusion Pumps in First Classwide Action

Calling it a first for the agency, CDRH Director Jeffrey Shuren says the FDA is exercising its authority across an entire class of devices — infusion pumps — because of “rampant problems” with the technology. Over the past five years, the FDA has received more than 56,000 reports of infusion pump-related adverse events, many resulting in serious injuries and more than 500 deaths. To address these problems, the agency has launched a multifaceted initiative that will include guidance, a public meeting May 25 and 26 and a website focusing on infusion pumps.
Devices & Diagnostics Letter