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  • All AEDs Would Require a Premarket Approval Under New Rule Proposed by FDA

    US regulators have proposed a new rule that would require all automated external defibrillators (AEDs) to undergo the premarket approval (PMA) process for approval due to concerns that deficient or malfunctioning devices had been a contributing factor in the deaths of some patients. Background The US Food and Drug Administration (FDA) has since 2011 been considering the reclassification of AEDs from their current Class II ( Editor's note: the devices are actually Clas...
  • US Regulators Move to Reclassify Medical Device as Class III

    The US Food and Drug Administration (FDA) announced Friday, 6 July that it wants to require sponsors of shortwave diathermy (SWD) devices to file either a premarket approval application (PMA) or complete a product development protocol (PDP) for all but one of the device's indications. SWDs are used to generate deep heat in body tissues using electromagnetic energy. Though they are primarily used to raise the heat of the body tissue, some medical device manufacturers have...
  • US Regulators Reclassify Pacemaker Electrodes as Higher-Risk Devices

    • 06 July 2012
    After a series of problems in which permanent pacemaker electrodes have been associated with adverse events, the US Food and Drug Administration (FDA) said it will reclassify the electrodes as Class III medical devices. As a result of the reclassification, manufacturers of permanent pacemaker electrodes will now be required to submit either a premarket approval application (PMA) or complete a product development protocol (PDP) in order to legally market a permanent pacema...