Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff

Issue Date: February 21, 2023
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Physical Medicine
Status: Final

Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff

This guidance document provides recommendations for 510(k) submissions for ultrasonic diathermy devices, also known as physiotherapy devices. Ultrasonic diathermy devices are devices under section 201(h) of the Federal Food, Drug and Cosmetic Act (the FD&C Act). This guidance includes recommendations on the use of certain International Electrotechnical Commission (IEC) standards in generating information that can support 510(k) submissions for these devices. This guidance also supplements other FDA documents regarding the specific content requirements and recommendations of a premarket notification (510(k)) submission (also refer to 21 CFR 807.87).

Download the Guidance Document