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  • Electrosurgical Devices Subject of Two New FDA Guidance Documents

    The US Food and Drug Administration (FDA) has released two new draft guidance documents intended to clarify the premarket notification requirements for electrosurgical devices. Background Premarket notification-also known as the 510(k) pathway-represents a faster and less expensive path to market than the premarket approval process, which requires the submission of full clinical data illustrating the safety and efficacy of a device. By contrast, premarket notifications ...
  • New Electrosurgery Device Cleared for NHS Use

    The UK's National Institute of Health and Clinical Excellence (NICE), the country's health technology assessment agency, has cleared a new high tech monopolar electrosurgery device (Mega Soft Patient Return Electrode) for use by the National Health Service (NHS). The final guidance , issued on 22 August, advises that use of the device could help reduce the risk of localized burns during monopolar electrosurgery in select patients, such as those who would require shavin...