Among other requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations, ultrasonic diathermy devices, also known as ultrasonic therapy or physiotherapy products, must comply with 21 CFR Part 1010 and 1050.10. This guidance document describes FDA’s recommendations for the performance standard requirements in 21 CFR 1050.10 particular 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 of 21 CFR 1050.10, FDA does not intend to consider whether firms that provide a declaration of conformity and indicate conformance to applicable IEC standards also comply with 21 CFR 1050.10.

In addition, this guidance document also provides recommendations for information to provide in 510(k) submissions for these ultrasonic diathermy devices.