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    FDA Finalizes 510(k) Guidance for Electrosurgical Devices

    The US Food and Drug Administration (FDA) on Friday finalized two guidances intended to help makers of electrosurgical devices file 510(k) submissions to the agency. The guidances, Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery and Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery were first introduced in draft form in March 2014. Background Electrosurgical devices...
  • 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    The US Food and Drug Administration (FDA) has released two new draft guidance documents intended to clarify the premarket notification requirements for electrosurgical devices.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 ...