FDA Proposes More Oversight of AEDs

Manufacturers will be required to submit premarket approval applications. The proposed order is necessary because adverse event reports more than doubled from 2005 to 2010 and continue to rise, according to the agency.

The U.S. Food and Drug Administration issued a proposed order March 22 that will require manufacturers of automated external defibrillators and AED accessories to submit premarket approval (PMA) applications for them. The order's stated goal is to improve the quality of AEDs; the order's text states that FDA believes the way they are currently regulated "has not been successful," given the number of recalls and approximately 45,000 adverse event reports to FDA involving them between 2005 and 2012.

Adverse event reports submitted annually more than doubled from 2005 to 2010, and a review of reports submitted from 2011 and 2012 shows the number continues to increase, it states. A PMA must include all data and information on any known risk, the effectiveness of the device, and full reports of all preclinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought. The rule says a PMA must include valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness of the device for its intended use, explaining that valid scientific evidence is "evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use."

A PMA also includes a review of the manufacturer's quality systems and an inspection of its manufacturing facilities. Once approved, manufacturers must submit annual reports on their device's performance.

The manufacturers will have to submit their PMAs within 90 days after FDA's final order is published.

"However, because of the widespread distribution of AEDs, we are proposing to consider exercising enforcement discretion for devices lawfully distributed before the requirement to have a PMA goes into effect as long as manufacturers of such devices timely notify FDA of their intent to file a PMA within 90 days from the issuance of the final order. FDA intends to consider exercising enforcement discretion for 15 months from the date the final order is issued," the order states. "FDA intends to review any PMA for the device within 180 days. FDA is aware that many existing AED manufacturers have already obtained significant clinical data on their devices. In most cases, FDA believes the clinical data that has been submitted for AEDs in 10 510(k) applications will suffice as valid scientific evidence necessary to support a PMA. However, a small number of manufacturers may need to conduct an additional investigation to support approval. In those circumstances, FDA will consider the least burdensome means of gathering information, and will consider whether reliance on post-market controls can reduce the extent of data that would otherwise be required to show effectiveness."

FDA is accepting comments on the proposed order for 90 days. To comment, visit www.regulations.gov and search for Docket No. FDA-2013-N-0234.

"Automated external defibrillators save lives," said Dr. William Maisel, M.D., MPH, deputy director of science and chief scientist at FDA’s Center for Devices and Radiological Health. "However, the agency is concerned about the number of recalls and manufacturing problems that have been associated with these devices, and we’re committed to working with manufacturers to address these issues. If our proposed order is finalized, the FDA intends to focus its review of the pre-market applications on the more problematic aspects of AEDs."

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