FDA Approved AEDs

The Food and Drug Administration or FDA is responsible for the protection of public health by passing a certification of safety, efficiency, and security of both human and veterinary drugs, biological products and medical devices.

In addition to this, the FDA is also responsible for helping provide advanced care to the public by assisting in the innovation of beneficial medical products – including AEDs. Their contribution to this helps to make the most effective health solutions available to the public quicker whilst still ensuring the newly developed products are safe, affordable and inclusive of the vital scientific data to increase awareness of the need for the products.

What is FDA approval?

When a product is “approved” by the FDA, it has passed premarket approval (or PMA) and its application submitted by the FDA.

To receive final approval by the FDA through a PMA application, the applicant in question much provide sufficient assurance of the device’s safety and effectiveness which is then to be challenged by the FDA before finally becoming approved if requirements are met.

Why choose FDA?

Whilst all AEDs are designed to help increase chances of survival and even save the life of a cardiac arrest victim, FDA approved devices provide extra assurance that the unit in question has been vetted appropriately and has undergone substantial testing to ensure the device provides the most effective care possible, should it need to be used.

Many AED manufacturers test their own products to ensure the highest quality possible, however not all will undergo the same premarket approval as FDA approved devices and there is no stamp of certification if testing has taken place with non-FDA approved products.

Does FDA approved mean better?

Survival of cardiac arrest can never be guaranteed. It is the combination of effective CPR and defibrillation from an AED which must be applied immediately, which give the victim the highest chance of survival. To compare the effectiveness of one AED against another would be impossible to determine, however, an FDA approved unit assures the ability of certain products and guarantees the effectiveness of its functions.

FDA approval does not affect the price or promise of your AED, it simply provides additional confidence in the effectiveness and ability of a unit, should it need to be used in an SCA emergency.

If you have any further questions about FDA approved devices, or would like to learn more about what this means, please contact our knowledgeable AED specialists via savealife@thedefibshop.com