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FDA consults on AED (automatic external defibrillator) reclassification as access grows

This article was originally published in Clinica

Executive Summary

The US FDA is seeking comment on its planned reclassification of automatic external defibrillators (AEDs) from class III (high risk) to class II (medium risk), with the potential to greatly expand the market for the device. Class III devices must be approved for market via a premarket approval (PMA) application, whereas class II enables the device to be cleared via the 510(k) process.

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