Guide on Ultrasonic Diathermy Device 510(k)s

FDA has released a final guidance on “Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices.” The document describes agency recommendations for complying with the performance standard requirements for ultrasonic diathermy devices in 21 CFR 1050.10 where a manufacturer has otherwise complied with certain International Electrotechnical Commission (IEC) standards.  “Because conformance to certain IEC standards identified in this guidance adequately addresses the technical concerns intended to be addressed by the performance standard requirements, the FDA does not intend to consider whether firms who provide a declaration of conformity and indicate conformance to applicable IEC standards also comply with 21 CFR 1050.10,” the agency says. In addition, the guidance provides recommendations for information to provide in 510(k) submissions for such devices.