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FDA panel handles questions, concerns related to potential AED reclassification

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The FDA’s Circulatory System Devices Panel met today to discuss and make suggestions regarding the potential down-regulation of automatic external defibrillators from a class III device to class II status. Overall, the majority of panel members recommended AEDs maintain a class III status.

Under class III status, the device adheres to the premarket approval (PMA) approval process reserved for high-risk devices, which includes more stringent controls, more comprehensive premarket data-gathering requirements and additional safety requirements. Down-regulation to class II would allow AED approval to be regulated under the less-stringent 510(k) process, which includes fewer requirements prior to device approval than are required under a PMA. Under class II, the AED would be subject to the 510(k) process with special controls, scrutiny and monitoring to be added specifically for the AED class of devices.

After presentations earlier in the day from members of the FDA and industry, including one from Phillips Medical who had submitted a reclassification petition on August 5, 2009, the panel members deliberated on concerns that highlighted the lack of the certainty necessary to reclassify AEDs.

“First of all AEDs are phenomenally important devices and save far more lives than they harm,” said Richard L. Page, MD, with the University of Wisconsin at Madison. “That being said, I think we can do better. Today we heard that there was a 20% recall in 2006 and we’ve seen numbers where recalls have increased. I see us as having a problem and we need to find a regulatory answer to it. With all due respect to the FDA, if we start making up a whole bunch of new systems it troubles me that we would take longer to get it right as a 510k than a class III. So that is the direction that I would be inclined for.”

Following deliberation, the FDA questioned the panel members on what their specific recommendations were for AED classification. On the whole, the recommendations strongly favored maintaining class III status.

“I don’t think any of us think that making this class III with a PMA is going to give us new safety and efficacy data, but it sounds like class II with special controls is just too cumbersome to work at this stage and we know that class III with PMA works,” said Patricia A. Kelly, MD, of the Physician Center No. 2, Missoula, Montana. “So … for practical reasons I would think that class III with PMA would be the way to go.”

Myron L. Weisfeldt, MD, with Johns Hopkins University School of Medicine, Baltimore, who was among the minority who recommended class II with special controls, said of his suggestion, “[AED] is a technology that has been around for 26 years and its effectiveness … is beyond question. Really what we need is special controls that ensure that the limitations we noted today are addressed.”

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