The FDA has invited public commentary regarding its proposal to reclassify automated external defibrillators (AEDs) as high-risk class III medical devices. The deadline for submitting comments is today, June 24, 11:59 ET.
The Sudden Cardiac Arrest Foundation has urged the FDA to instead regulate AEDs as class II medical devices with special controls, a designation will that foster more widespread deployment of AEDs and encourage innovation, while minimizing risk. The Foundation also recommends initiatives to raise awareness, increase CPR-AED training among laypersons, increase AED deployment, and improve systems to ensure device readiness. For more information, click here.
To date, all comments that have been published on the FDA website urge the FDA not to reclassify the lifesaving devices as high-risk devices. To read the comments, click here.
To submit your comments, click here and specify Docket No. FDA-2013-N-0234.
To join the 1,232 people who have signed a petition to the FDA initiated by the SCA Foundation on the matter, click here by 11 pm ET.
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