Automated External Defibrillators (AEDs)
For Purchasers and Clinical Engineers
For Patients and Consumers
Automated external defibrillators (AEDs) are portable, life-saving devices designed to treat people experiencing sudden cardiac arrest, a medical condition in which the heart stops beating suddenly and unexpectedly.
The combination of CPR and early defibrillation is effective in saving lives when used in the first few minutes following a collapse from sudden cardiac arrest.
On this page
- What Are AEDs?
- Check Your AED and AED Accessories: Are They FDA Approved?
- FDA-Approved AEDs
- FDA-Approved AED Accessories
- Important Information for AED and AED Accessory Manufacturers
- The FDA's Continued Efforts to Keep AEDs Reliable
What Are AEDs?
AEDs are a type of computerized defibrillator that automatically analyzes the heart rhythm in people who are experiencing cardiac arrest. When appropriate, it delivers an electrical shock to the heart to restore its normal rhythm. The AED system includes accessories, such as a battery and pad electrodes, that are necessary for the AED to detect and interpret a person's heart rhythm and deliver an electrical shock if one is needed. 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 and AED Accessories: Are They FDA Approved?
There are FDA-approved AEDs and AED accessories available, and we encourage you to ensure your AED and AED accessories are FDA-approved; if they are not, we encourage you to transition to FDA-approved AEDs and AED accessories.
If you or your organization owns an AED system, the FDA recommends you:
- Check the tables below to see if your AED system and AED accessories are FDA-approved.
- Contact the manufacturer of your AED or necessary AED accessories if:
- You are not sure if your AED or AED accessories are FDA-approved or
- They are not FDA-approved and you have not received a letter from the manufacturer.
- Select and purchase necessary AED accessories directly from authorized retailers to help ensure that you are purchasing an FDA-approved device.
- Locate the unique device identifier (UDI) on the AED or AED accessory product labels before you purchase them and consider searching the UDI in the AccessGUDID Database. The Global Unique Device Identification Database (GUDID) lists most medical devices legally sold in the U.S. from manufacturing through distribution to patient use.
- Continue to keep your AED available for use, even if it is not FDA-approved, until you obtain an FDA- approved AED, given the importance of these devices in emergency situations.
- 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, 2022.
- Report problems with AEDs and AED accessories to the FDA by submitting a voluntary report online at MedWatch.
FDA-Approved AEDs
The table below lists all AEDs that have received premarket approval from the FDA. If your AED is listed below, no matter your purchase date, the AED is considered FDA-approved. The FDA will update this table when new AEDs are approved. For descriptions of these devices, their indications for use, and related information, follow the Premarket Database links.
Important: If your AED is not listed in this table, please contact the manufacturer of your AED for more information about your device.
FDA-Approved AED Accessories
The table below lists all necessary AED accessories that have received premarket approval from the FDA and the FDA-approved AED for which it is compatible. The FDA will update this table when new AED accessories are approved.
For more information about the FDA approval of these accessories, their indications for use, and related information, follow the Premarket Database links.
Important: If your AED accessory is not listed in this table, please contact the manufacturer of your accessories for more information about your device.
Important Information for AED and AED Accessory Manufacturers
To ensure the quality and reliability of AEDs, the FDA requires manufacturers to obtain premarket approval for all AEDs and AED accessories.
The FDA expects that necessary AED accessories will be labeled for use with an FDA-approved AED device (on the list above). Manufacturers submitting a premarket approval application (PMA) for necessary AED accessories should be aware that they can continue to market those accessories while the PMA is pending until the FDA issues a decision (approval, not approvable, or denial decision). After a PMA decision is made, only FDA-approved accessories can continue to be marketed.
The FDA's premarket approval of new and existing AEDs and AED accessories is based on a determination that the application contains sufficient valid scientific evidence to reasonably assure the device is safe and effective for its intended use. This regulatory pathway requires manufacturers to receive FDA approval before initiating design, manufacturing, or labeling changes to the device, and imposes certain annual reporting requirements.
Once the AEDs and AED accessories are on the market, the FDA proactively monitors their safety and reliability by reviewing the manufacturers' manufacturing and design changes, performance reports, and medical device reports (MDRs). When a company initiates a correction or removal action, the FDA posts information about the action in the public Medical Device Recall database. Once classified, the FDA monitors the recall to ensure the recall strategy has been effective.
The FDA's Continued Efforts to Keep AEDs Reliable
The FDA recognizes the importance of AEDs as life-saving devices. Problems associated with AEDs include design and manufacturing issues, such as inadequate control of components purchased from suppliers or inadequate validation of manufacturing processes. When this occurs, an AED can malfunction and may contribute to patient harm or prevent the rescue of the patient.
Given this, the FDA has taken several actions to assure that current and future AEDs and necessary accessories are safe and reliable. These actions include:
- November 2022: The FDA sent letters to AED accessory manufacturers who did not submit a PMA for their AED accessories as required by the final order reminding them that they can no longer market their AED accessories.
- By February 3, 2022: Manufacturers of previously-cleared necessary accessories (such as batteries, pad electrodes, adapters) for the operation of AED systems that are FDA-approved were required to file a premarket approval application (PMA).
- October 27, 2020: FDA revised its compliance policy regarding the deadline for filing a PMA for previously-cleared necessary AED accessories until February 3, 2022. This revised compliance policy allowed health care facilities and manufacturers to remain focused on public health needs related to the COVID-19 public health emergency, while allowing time to transition to FDA-approved AEDs.
- By February 3, 2020: Original date manufacturers of previously-cleared necessary accessories (such as batteries, pad electrodes, adapters) for AED systems that are FDA-approved were to file a PMA.
- April 2019: The FDA sent letters to all AED manufacturers, who did not submit a PMA for their AEDs as required by the final order, reminding them they can no longer market their AED; the letters also informed the manufactures that necessary AED accessories may not be marketed after February 3, 2020, if a PMA is not filed. Manufacturers were asked to provide a plan for these AEDs and necessary AED accessories, including a timeline for servicing and phase-out activities, a plan for communicating with their customers, and an estimate of the volume of AEDs and accessories that remain in the field.
- November 1, 2017: The FDA and Philips Medical Systems LLC entered a consent decree of permanent injunction prohibiting Philips Medical Systems, Philips Healthcare, and those individually named from manufacturing, processing, packing, holding, or distributing AEDs from two facilities until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
- February 2015: The FDA published a final order in February 2015 requiring premarket approval (PMA) applications for new and existing AEDs and necessary AED accessories.
- December 2013: The FDA issued a Safety CommunicationExternal Link Disclaimer alerting all users of the Philips HeartStart FRx, HS1 Home and HS1 OnSite AEDs manufactured between 2005 and 2012 that these devices may fail to deliver a shock in the event of an emergency.
- March 2013: The FDA published a proposed order to allow for notice and comment regarding the FDA's recommendation to require premarket approval (PMA) applications for AEDs and necessary AED accessories.
- January 2011: The FDA convened a public meeting of the Circulatory System Device Panel of the Medical Devices Advisory Committee where the FDA presented its comprehensive assessment of AEDs. The panel of independent experts considered the FDA's assessment of AEDs and its recommendation that more stringent FDA oversight be applied to reduce future AED problems. The panel agreed with the FDA's recommendation to require PMA applications for AEDs.