FDA Issues Proposal to Improve Quality of Automated External Defibrillators
Proposal Protects Access to Critical Medical Device
The U.S. Food and Drug Administration today issued a proposed order aimed at helping manufacturers improve the quality and reliability of automated external defibrillators (AEDs). The proposed order, if finalized, will require manufacturers of these life-saving devices to submit pre-market approval (PMA) applications.
AEDs are portable, electronic medical devices that automatically re-establish normal heart rhythms with electrical stimulation when they sense potentially life-threatening cardiac arrhythmias. Although these devices have saved lives over the years, the FDA has received approximately 45,000 adverse event reports between 2005 and 2012 associated with the failure of these devices. Manufacturers have also conducted dozens of recalls. The problems the FDA is seeing with AEDs are preventable and correctable. The most common issues involve the design and manufacture of the devices and inadequate control of components purchased from other suppliers.
“Automated external defibrillators save lives,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the 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.”
The FDA will make sure that automated external defibrillators remain available so that they can continue to save lives. Although there have been problems associated with AEDs, their life-saving benefits outweigh the risk of making them unavailable during the classification process.
Ultimately, the proposed review process will allow the agency to more closely monitor how these devices are designed and manufactured. This will go a long way towards improving this life-saving technology.
The recently enacted Food and Drug Administration Safety and Innovation Act calls for the FDA to publish a proposed and final order to reclassify or call for PMAs for a pre-amendments device. The FDA’s Circulatory System Devices Panel recommended that AEDs remain Class III medical devices and require PMAs. The FDA is issuing this proposed order and calling for PMAs as part of the 515 Program to ensure the appropriate regulation of Class III pre-amendments devices.
PMA applications are required to contain clinical data to support a product’s approval. However, adds Maisel, “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.”
In addition to the clinical safety and effectiveness data, a PMA must also include a review of a manufacturer’s quality systems information and an inspection of its manufacturing facilities. After approval, manufacturers must submit to the FDA any significant manufacturing changes made to the devices as well as annual reports of the device’s performance.
The FDA will take comments on the proposed order for 90 days. If the proposed order is finalized, the FDA intends to exercise enforcement discretion for those manufacturers that notify the FDA of their intent to file a PMA in a timely manner. The FDA intends to exercise enforcement discretion for a year and a half.
March 22, 2013
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