PMA Series – Part 4: Consequences of Non-PMA Devices
FDA’s new stringent evaluation standards are set to improve dependability of automated external defibrillators (AEDs). What are the penalties of using non-Pre-Market Approved devices? Q: What are the consequences of purchasing and using a non-PMA device? A: While it is unlikely that the FDA is going to randomly catch users of non-PMA devices and fine them, we do see significant risks to using...