FDA alters review process for AEDs
Washington – The Food and Drug Administration has updated its review process for automated external defibrillators in an attempt to make the products more reliable.
FDA published a final rule Jan. 29 in the Federal Register requiring manufacturers to submit pre-market approval applications for AEDs. By requiring pre-market approval, FDA said, the agency can learn more about manufacturers’ Quality System information. The agency also will inspect manufacturers’ facilities before approval.
FDA plans to enforce the rule beginning July 29, 2016. That is contingent upon manufacturers notifying FDA of their plan to file a pre-market approval application by April 29, 2015.
Although AEDs offer great benefits, malfunctions have been reported. From January 2005 to September 2014, FDA said it received about 72,000 reports that involved AED failures. Meanwhile, AED manufacturers have issued 111 recalls since 2005.
“These changes to the way [AEDs] are reviewed will allow us to more closely monitor how they are designed and manufactured,” William Maisel, acting director of the Office of Device Evaluation in FDA’s Center for Devices and Radiological Health, said in a press release. “This will go a long way toward correcting long-standing problems and ultimately improving the reliability of these devices.”