FDA Approved AEDs

As of February 3rd, the Federal Drug Administration requires a Premarket Approval (PMA) for any AED, AED accessories, and professional defibrillators. This mandate has been six years in the making, with many manufacturers having already updated their catalogs to be FDA-compliant. It’s paramount to ensure that all your AEDs are FDA compliant before the 5th.

Premarket Approval will ensure all the facts about an AED are stated clearly and consciously on the FDA’s website. This database will include the PMA number, the date of the decision, who the applicant was, and a statement on why the device was approved. The database also includes information on whether the AED can be used in cases of pediatric/infant cardiac arrest. With this resource, buyers and businesses will be able to determine if an AED is correct for their needs, as well as know all stated facts about an AED have been confirmed by the US government.

Applications for AED PMAs take about one year to file with the FDA, so companies that require approval for their devices will need to withdraw their inventory until their AEDs receive a PMA. AEDs should be reliable, so faulty devices or parts can result in preventable death. This order will add an increased level of reliance and ease of mind for customers. Knowing that a life-saving AED will work after purchase 2-3 years ago.

What should you do IF your AED is not FDA-approved? Thankfully, CPR Savers has your back! We offer AEDs for retail purchases as well as cabinets, emergency kits, and alarms. If budgets are tight this quarter and you’re unsure if you can afford an AED, we can also offer grants to those that apply! With all this in mind, there’s no reason not to check your AEDs and ensure they are FDA-approved and have a PMA on them.

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