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AEDs Save Lives. Let's Keep Them Readily Available.
Petition Background (Preamble):
The FDA, however, is considering new regulations that will drastically reduce access to the user-friendly lifesaving devices. The FDA is in the process of reclassifying “pre-amendment class III devices,” including AEDs. If AEDs are reclassified as class III devices, unnecessary regulatory hurdles will increase and access to early defibrillation will decrease, drastically reducing the odds of survival for victims of sudden cardiac arrest.
If you are someone who works every day to help save lives, or if you have been personally affected by SCA and understand the critical importance of early defibrillation, please express your concerns to the FDA now, before their determination is made. A decision is anticipated by June 2013.
We, the undersigned, urge the Food and Drug Administration to refrain from reclassifying automated external defibrillators (AEDs) as class III devices requiring pre-market approval. Decades of research and experience support the fact that AEDs are safe and effective user-friendly devices that can and do save lives.
We urge you to do everything within your power to ensure that AEDs are widely deployed and readily available for use by bystanders, whenever sudden cardiac arrest strikes.
The AEDs Save Lives. Let's Keep Them Readily Available. petition to Food and Drug Administration was written by Sudden Cardiac Arrest Foundation and is in the category Health at GoPetition. Contact author here. Petition tags: sudden cardiac arrest, automated external defibrillators, aeds, food and drug administration, fda, defibrillation, survivor