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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

How big is the effect on AED manufacturers?

For the industry, then, the question is: how onerous are these changes? So far, it’s not exactly clear, but potentially the effect is quite large, as higher-risk devices take months longer, and millions of dollars more, to get approved for market.

“Generally, PMA approval imposes a significant time and financial commitment on companies seeking such approval,” AED-maker Philips Healthcare told DOTmed News in an e-mail. “The added costs associated could ultimately increase the cost to consumers, which is already significant given that AEDs are not reimbursed by insurance.”

Still, based on talks between the FDA and industry on March 21, Philips said it doesn’t believe the rules, if final, would interrupt its AED distribution in the U.S.

“Philips continues to review the proposed order, and remains committed to working with the FDA to ensure the best application of technology and clinical experience in support of AED performance and reliability,” the company said.

Brian Webster, the president and CEO of PhysioControl, an AED manufacturer that recently was bought by Bain Capital (of Romney fame) from Medtronic, said his company has “the most-robust quality system in the industry” and as a result is also “extremely confident” it can meet the new regulations.

“The move would level the playing field and require all AED manufacturers, including third-party suppliers, to adhere to the same high quality standards,” he said in a statement sent to DOTmed News. In any case, he said it was important to remember that “AEDs save lives and that device failures are extremely rare.”

“While it is the FDA’s position that defibrillator failures have risen, the number of devices in the market has grown exponentially and AED reliability continues to improve,” he added.

Other manufacturers, such as HeartSine and Zoll, did not respond to requests for comment by press time.

But some numbers will help put the debate into context. A Class II application, going from submission to final 510 (k) clearance, takes 138 days on average, according to Elisa Maldonado-Holmertz, VP of business development at Emergo Group, a company that consults with device manufacturers about regulations. For a Class III device, on average it’s 540 days.

“It’s a substantially longer timeframe for manufacturers to make it to market access,” Maldonado-Holmertz says. “That’s a significant difference.”

The costs are higher too. A 510(k) application is $4,950, whereas a PMA is $258,000. Potentially, though, AED makers could spend a lot more, depending on the burden of clinical evidence required.

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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