Comments Submitted to the FDA Regarding Automated External Cardiac Compressor Devices
April 8, 2013
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Public Citizen urges the FDA to withdraw its proposal for Class II reclassification of automatic external cardiac compressor devices for chest compressions during cardiopulmonary resuscitation (CPR) because there is a lack of evidence that they are safe and effective. The FDA should instead publish a proposed final rule maintaining the devices’ Class III designation and set an effective date requiring the submission of evidence that the devices are safe and effective.