Jan 25, 2011

Manufacturers of automated external defibrillators (AEDs) will likely have to begin submitting premarket approval (PMA) applications for their products in the US based on rumblings at the Food and Drug Administration (FDA). Such a move would have significant ramifications for both new and current manufacturers accustomed to less strenuous—but probably inadequate—clearing processes. AED manufacturers can currently submit 510(k) applications for product clearance even though their devices fall under the high-risk Class III category, which would typically require more rigorous PMA applications. Prompted by a Government Accounting Office (GAO) recommendation last year to update regulations for Class III devices permitted to submit 510(k)s, however, the FDA has since investigated whether AEDS should now fall under the Class II category in order to continue their 510(k) submissions or retain their Class III status and undergo comparatively onerous PMA approval processes, which include significant clinical trial requirements. Although the FDA will convene a panel of experts today (January 25) to discuss the pros and cons of either approach, the agency has clearly indicated a strong leaning toward keeping AEDs classified as Class III devices and requiring PMA submissions not only for new products, but also existing ones currently sold in the US. All current AED manufacturers submitted reclassification petitions, unsurprisingly unanimous in urging reclassification of their devices to Class II. But after conducting its own review of AED performance testing, device recalls and medical device reports, the FDA concluded that these devices should remain in the Class III category and comply with PMA submission requirements. Citing various results of its analysis of 68 AED devices recalled between January 2005 and August 2010, the FDA argues that requiring PMA rather than 510(k) submissions would help curb major manufacturing, quality assurance and quality system shortcomings contributing to rising recall rates in the last few years. The FDA will not issue a final decision on AED reclassification until after the views of its expert panel are considered. Manufacturers to be affected by the FDA's decision include Cardiac Science Corporation, CU Medical Systems, Defibtech, Heartsine Technologies, Philips Medical Systems, MedTronic's Physio-Control Corporation, and Zoll Medical Corporation.


  • Stewart Eisenhart