Automated External Defibrillators (AEDs)

Automated External Defibrillators (AEDs) and manikin

What Are AEDs?

AEDs are portable, life-saving devices designed to treat people experiencing sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. The AED system includes accessories, such as a battery and pad electrodes, that are necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock. There are two main types of AEDs: public access and professional use.

  • Public access AEDs can be found in airports, community centers, schools, government buildings, hospitals, and other public locations. They are intended to be used by laypeople who have received minimal training.

  • Professional use AEDs are used by first responders, such as emergency medical technicians (EMTs) and paramedics, who receive additional AED training.

AEDs can be semi-automated or fully automated.

  • Semi-automated defibrillators analyze the heart’s rhythm, and if an abnormal heart rhythm is detected that requires a shock, then the device prompts the user to press a button to deliver a defibrillation shock.

  • Fully automated defibrillators analyze the heart’s rhythm and deliver a defibrillation shock if commanded by the device software without user intervention.

Check Your AED: Is it FDA Approved?

Automated External Defibrillators (AEDs)

The FDA published a final order in February 2015 requiring premarket approval (PMA) applications for new and existing AEDs and necessary AED accessories. Manufacturers of all necessary AED accessories, such as batteries, pad electrodes, adapters and hardware keys for pediatric use, must file a premarket approval application (PMA) by February 3, 2020. If a PMA is not filed by February 3, 2020, the manufacturer must cease marketing their accessories by February 3, 2021.

There are now FDA-approved AEDs available, and we encourage you to ensure your AED is FDA-approved; if it is not, we encourage you to begin making plans to transition to an FDA-approved AED.

  • If you or your organization own(s) an AED system, the FDA recommends you:

  • Check this table to see if your AED is FDA-approved. Contact the manufacturer of your AED if you are not sure if your AED is FDA-approved.

  • Contact the manufacturer of your AED if your AED is not FDA-approved and you have not received a letter about your AED.

  • Be aware that if your AED is not FDA-approved, compatible necessary AED accessories may no longer be available to support your AED after February 3, 2021.

  • Contact the manufacturer of your AED or AED accessories for information specific to your product.

  • Given the importance of these devices in emergency situations, the FDA recommends you continue to keep your AED available for use until you receive an FDA- approved AED.

  • Report problems with AEDs to the FDA by submitting a voluntary report online at MedWatch.