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AED manufacturers get regulatory jolt

by Brendon Nafziger, DOTmed News Associate Editor | May 07, 2013
From the May 2013 issue of HealthCare Business News magazine

For now, that’s not clear, either. In its comments, the agency suggested that most AED manufacturers already have enough data for devices out on the market. “In most cases, FDA believes the clinical data that has been submitted for AEDs in 510(k) applications will suffice as valid scientific evidence necessary to support a PMA,” the FDA said in the proposed order.

The agency did note, however, that a “small number” of companies would need “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,” the agency said. The agency also noted that one PMA application could cover all of a manufacturer’s models, according to a March Reuters report.

Still, if clinical trials are needed for at least upcoming, brand-new devices, they could be expensive, depending on how the new position is enforced. Previously, most AEDs only needed a usability study, Maldonado-Holmertz explains, such as whether a bystander could pull the device off the wall and use it safely. These typically had no more than 20 to 50 participants. But for a PMA, manufacturers could potentially require a large-scale true clinical trial to prove safety and efficacy. This would involve possibly 200 to 250 subjects.

The price difference is huge, too. Small usability studies tend to run from $20,000 to $800,000, depending on their complexity, Maldonado-Holmertz says. But true clinical PMA trials can cost upwards of $3 million.

Will the increased costs be a problem? “For researchers and AED manufacturers committed to driving innovation to help improve survival from SCA, some may find that it is only feasible to conduct research outside the U.S. given the regulations associated with Class III,” Philips said. “The resulting advanced technology may only be made available in markets outside the U.S. due to differing AED regulations in other geographies.”

But others aren’t so sure. Public Citizen’s Caroome is skeptical that being regulated as a Class III product will dry up the market, as some AED advocates or manufacturers have feared.

“That’s a common refrain you hear, that ‘Oh, these devices, we won’t be able to afford to do this,’” he says. “There are companies out there that will still be able to make these out there with appropriate testing. Using language out there to scare the public isn’t helpful.”

DOTmed Registered DMBN May 2013 - Defibrillators Companies


Richard Lazar

AED Reclassification – When Near Perfect is Not Enough for FDA

May 17, 2013 04:27

The FDA is proposing to reclassify AEDs as Class III medical devices. This change will require manufacturers to go through a much more time consuming and costly regulatory process before their AEDs can be sold. Why? According to the agency’s proposed rule, the primary purpose of reclassification is to reduce the risk of illness or injury resulting from AED failures. Yet, a study relied upon by the agency finds that AEDs work as intended during rescue attempts greater than 99% of the time. This is a clear example of the perfect as the enemy of the good (or even great) driving a regulatory action that will cost lives and money with very little public health benefit.

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