Zdrowie i gospodarka · 16.04.2018

Policy Clarification and Premarket Notification Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff." This guidance clarifies FDA's policy related to compliance with applicable performance standards and conformance to International Electrotechnical Commission (IEC) consensus standards for ultrasonic diathermy devices. This guidance provides recommendations for information to provide in 510(k) submissions for ultrasonic diathermy devices.