New FDA Guidelines on AED Purchases

February 25, 2020

The FDA in February 2015 published an order requiring pre-market approval (PMA) for new and existing AEDS with an implementation deadline of February 2021. They note, "If your AED is not FDA-approved, the accessories necessary for your AED may no longer be supported by the manufacturer, and thus will no longer be available after February 3, 2021."


It's important to identify FDA-approved AEDs, or those that have applied for approval, and determine whether your current solution meets the criteria identified by the FDA.


Con10gency works closely with ZOLL on AED, AED accessories, and maintenance support systems. They recently released guidance in conjunction with the FDA on how to proceed in light of these new market requirements. Please review their informative statement, and contact us with any questions or assistance we can provide. As always, we're here to help!


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