FDA Requires Premarket Approval for Automated External Defibrillators

August 31, 2016 | Evaluations & Guidance


On January 28, 2015, FDA announced a final order that requires manufacturers to begin submitting premarket approval (PMA) applications for their new and currently marketed automated external defibrillators (AEDs)—including all external defibrillators that can function as an AED. This order takes the place of the previous requirement that AEDs undergo the less stringent 510(k) premarket notification process.

The order stems from FDA's concerns about the large number of AED safety and reliability problems: Between January 2005 and September 2014, FDA received approximately 72,000 adverse event reports related to AEDs, and manufacturers initiated over 100 recalls. The agency says that the problems most commonly relate to the design and manufacture...

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