Comments Submitted to the FDA Regarding Automated External Cardiac Compressor Devices
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.