Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices

Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices

Today, the Food and Drug Administration (FDA) released a final guidance document, "Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices." This guidance describes FDA’s recommendations for complying with the performance standard requirements in 21 CFR 1050.10 related to ultrasonic diathermy devices when 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. In addition, this guidance document provides recommendations for information to provide in 510(k) submissions for these ultrasonic diathermy devices. Food and Drug Administration Center for Devices and Radiological Health