PMA Series – Part 3: Where You Buy is Important

FDA's new stringent evaluation standards are set to improve dependability of automated external defibrillators (AEDs). Are you curious why non-Pre-Market Approved devices are being so heavily discounted? To view devices that are still compliant to the FDA’s ruling and the PMA, click here. Q: Why are some distributors still selling these devices in the U.S.? A: Great Question. The FDA...

PMA Series – Part 2: Affected Devices

FDA’s new stringent evaluation standards are set to improve dependability of automated external defibrillators (AEDs). This is part 2 of the DXE Medical PMA Series regarding important information you should know about the FDA’s recent change in regulations on AED Pre-Market Approval (PMA) requirements. Q: Does the FDA’s ruling apply to only AEDs or also to manual defibrillators with an AED...