Posted by SCAFoundation on 03/22/2013

Re: FDA Issues New Proposals to Improve Quality of AEDs

The Sudden Cardiac Arrest Foundation is opposed to the FDA's proposed reclassification of automated external defibrillators (AEDs) as Class III devices. Our Sudden Cardiac Arrest Survivor Network is a testament to the fact that AEDs save lives. It has taken so long to improve rates of survival from sudden cardiac arrest. Let's not take a giant step backwards.

We are encouraged by the FDA's statement that "The FDA will make sure that AEDs remain available so that they can continue to save lives... their life-saving benefits outweigh the risk of making them unavailable during the classification process." We are also encouraged to know that "The FDA has announced the opportunity for interested persons to request that the FDA change the classification of the AEDs based on new information."

The current 510K application costs about $5,000, whereas the proposed PMA application costs nearly $250,000. Needless to say, the additional costs will be passed on to AED acquirers such as schools, colleges, sports groups, churches, businesses and other public access locations. Unfortunately, this will likely lead to reduced access to AEDs and potentially the loss of life.

To date, the SCA Foundation has testified before the FDA (see links below), submitted letters to the FDA (attached), written a letter to the editor published in The New York Times, written a blog published in The Huffington Post, created an online petition that has attracted nearly 700 individuals including many survivors, and spoken with reporters on the topic.

Here are some links to additional information from the SCA Foundation on the issue:

We encourage concerned individuals and organizations to sign our petition to the FDA here.

Look for new initiatives by the Sudden Cardiac Arrest Foundation during the upcoming commentary period.

Comments

Thank heavens that Sudden Cardiac Arrest Foundation exists to advocate for the general public whose lives are saved by AEDs. Thank you for paying attention to these matters that affect the lives of the future hundreds of thousands who will die in the next 12 months without CPR and AEDs. Maybe we should get Joe Biden onto it.

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