What is the FDA?

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

What is FDA premarket approval?

The U.S. Food and Drug Administration has announced that it will strengthen its review of automated external defibrillators (AEDs) to help improve the quality and reliability of these devices. By requiring premarket approval for these devices, the FDA will receive important information about an AED manufacturer’s quality systems information. The FDA will also conduct inspections of manufacturers’ facilities prior to approval. After approval, manufacturers will be required to submit to the FDA any changes made to the devices that affect safety or effectiveness, and annual reports on device performance.

Why Is FDA taking action?

AEDs can save lives – but the devices have been associated with manufacturing problems and many devices have been recalled.
To help to assure the quality and reliability of AEDs, the FDA is requiring manufacturers to obtain premarket approval for all future and currently-marketed AEDs and necessary AED accessories (e.g., pad electrodes, batteries, adapters and hardware keys for pediatric use).
From January 2005 through September 2014, the FDA received approximately 72,000 medical device reports associated with the failure of these devices. Since 2005, manufacturers have conducted 111 recalls, affecting more than two million AEDs. The problems associated with many of these recalls and reports included design and manufacturing issues, such as inadequate control of components purchased from other suppliers.

Why does New Zealand Red Cross only sell AEDs and replacement parts for FDA approved Devices?

Whilst all AEDs can be used to save a life in the event of a cardiac arrest, FDA approved devices provide that extra piece of mind that the specific unit being used has undergone vigorous and substantial testing to ensure that that particular piece of equipment operates just as it should and provides the most effective care possible. New Zealand has one of the most open markets and while this good for some things we believe it makes it difficult when choosing lifesaving equipment. Many of the AEDs are sold in New Zealand cannot be sold in other countries around the world.