FDA issued a proposed order March 22 requiring PMAs for automated external defibrillators. FDA received approximately 45,000 adverse event reports associated with the devices between 2005 and 2012, and AED manufacturers have conducted 88 recalls, according to FDA. The agency says the most common problems have involved the design and manufacture of the devices and inadequate control of components purchased from suppliers. In January 2011, FDA’s Circulatory System Devices panel recommended that the pre-amendment devices remain in class III with new PMA requirements; AEDs currently enter the market via the 510(k) pathway. (See Also see "FDA Advocates PMAs For Automated External Defibrillators" - Medtech Insight, 31 January, 2011..)
Under the proposal, companies must submit clinical safety and effectiveness data, along with information on their manufacturing quality system. AED firms will also be subject to a pre-approval FDA inspection...
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