Posted by SCAFoundation on 11/02/2012

The Food and Drug Administration is in the process of reclassifying "pre-amendment class III devices," including automated external defibrillators (AEDs). This proposed increase in regulations will have significant public health consequences, due to reduced access to early defibrillation for the nation's victims of sudden cardiac arrest. If regulatory hurdles increase, access to lifesaving treatment with AEDs will decrease. Following is our letter to the FDA.

We urge you to express your concerns to the FDA as soon as possible, before a determination is made. Sign this petition. Or use the sample letter below.

More coverage: Journal of Emergency Medical Services

A Letter from the Sudden Cardiac Arrest Foundation to the Food and Drug Administration:

Dear Sirs:

The Sudden Cardiac Arrest Foundation is a national nonprofit 501(c)(3) organization whose mission is “to raise awareness and support programs that give ‘ordinary people’ the power to save a life.”

We are writing to express our concern that the Food and Drug Administration is considering reclassification of automated external defibrillators (AEDs) as Class III Devices requiring pre-market approval. We believe that increased regulation of the user-friendly lifesaving devices—proven irrefutably safe and effective by decades of research—would demonstrate a lack of understanding about the life-threatening condition of sudden cardiac arrest and would have a profoundly harmful effect on unsuspecting victims, greatly reducing their chances of survival.

As you are certainly aware, sudden cardiac arrest is a leading cause of death in the U.S., affecting more than 1,000 people each day (382,800 people annually) and on average, only eight percent of victims survive. [1] Survival rates increase slightly when victims receive bystander CPR, however, survival rates increase dramatically to 38 percent when victims receive both CPR and treatment with AEDs by bystanders. If all SCA victims had timely access to treatment with AEDs and the average survival rate increased to 38 percent, more than 100,000 additional lives could be saved each year. [2]

We believe the FDA would be prudent to reconsider the proposed increase in regulations, and instead focus on ensuring that AEDs are widely deployed and the public is informed about the importance of using the lifesaving devices—without hesitation—in cases of sudden unexpected cardiac death. We urge the FDA to redirect its energy and resources to help raise awareness about the need for immediate bystander intervention with AEDs.

Our Sudden Cardiac Arrest Survivor Network is a testament to the fact that a quick combination of CPR and defibrillation is nothing less than the key to survival. Earlier this fall, we co-hosted a gathering of survivors from around the U.S., who would be quick to point out they owe their lives to the timely use of AEDs.

Perhaps our national spokesperson, TV news anchor and sudden cardiac arrest survivor, Susan Koeppen, 39, says it best: “If it were not for the bystanders who rushed to help me, I would not be here today. I can’t stress enough the importance of learning CPR and how to use an AED.”

Robust AED safety and performance standards already exist that capture more than 20 years of hard-won clinical, regulatory, and industry experience.

We urge the FDA to consider alternative pathways that ensure the safety and effectiveness of AEDs, and at the same time support efforts to drive widespread access to early defibrillation.

It has taken decades to get this far. We cannot afford to decrease the odds that victims in need will have timely access to definitive care.


Norman S. Abramson, MD, FACEP, FCCM, Chairman, Board of Directors

Mary M. Newman, MS, President

[1] Roger VL, et al. Heart Disease and Stroke Statistics-2012 update. A report from the American Heart Association. Circulation. 2012;125(1):188-197.

[2] Weisfeldt ML, et al. Survival after application of automatic external defibrillators before arrival of the emergency medical system: evaluation in the resuscitation outcomes consortium population of 21 million. J Am Coll Cardiol. 2012;55(16):1713-1720.

(See attachment.)

Related 2011 Letter to The New York Times

Sample Letter

The FDA is only accepting mail or faxed documents. Please feel free to use the sample letter below.

Food and Drug Administration
Division of Dockets Management (HFA-305)
Docket Number: FDA 2009-M-0101
Fishers Lane, Room 1061
Rockville, MD  20852

Fax: 301-827-6870

To U.S. Food & Drug Administration:

Early defibrillation is the definitive treatment for sudden cardiac arrest (SCA), which claims more than 300,000 lives in the United States per year. Widespread distribution of automated external defibrillators (AEDs) is overwhelmingly advocated by the medical community and legislators as a strategy for achieving early defibrillation. Even with the growing availability of AEDs in the US and highly successful early defibrillation programs throughout the country, the current national SCA survival rate is less than 8%, largely because without AEDs early defibrillation doesn’t happen in time. In order to improve the national survival rate and help restore more lives, we must continue to drive widespread access to AEDs.

It is my understanding that the FDA is considering classifying AEDs as class III, requiring pre-market approval (PMA). I am writing to express my concern that this increased regulation of AEDs will limit innovation and public access to these devices, both highly negative results. Over several decades, hundreds of peer-reviewed studies have already demonstrated that AEDs are safe and effective and that early defibrillation saves lives. There is no guarantee, and little likelihood that requiring AEDs to go through the PMA process will lead to an increase in AED safety and effectiveness. To the contrary, these additional regulations will likely stifle innovation and new, improved technology will be delayed, or may not even be pursued in the US due to regulatory costs and time-to-market considerations under the PMA process. 

Furthermore, AEDs will become more expensive to purchase and maintain as a direct result of expenses associated with increased regulatory requirements. Communities, public entities such as schools and police forces, companies, including small businesses, and non-profit organizations, are among the primary groups that provide the funds to purchase and maintain public access AEDs for which there is no insurance reimbursement. Moreover, to the extent individuals can now afford to have AEDs in their homes, this additional source of AED availability will surely diminish or disappear altogether. As prices rise, fewer AEDs will be purchased and deployed which limits public access AED availability when they are critically needed to help save lives. Without public access AEDs the average time to defibrillation will likely increase, which then could decrease survival in the US associated with SCA.

Robust AED safety and performance standards already exist that capture over 20 years of hard-won clinical, regulatory, and industry experience. These AED-specific standards are the foundation for securing consistent performance as they drive implementation of best practices across the industry. Perhaps focusing on broader support and continuous improvement of these standards would help achieve even improved product performance, while maximizing access to life-saving AEDs.   

I urge the FDA to consider alternative pathways that ensure the safety and effectiveness of AEDs, but at the same time continue to support efforts to drive widespread access to early defibrillation. For the hundreds of thousands of Americans who unexpectedly suffer an SCA each year, we cannot afford to further decrease the odds that an AED will be available when needed to help restore their lives.