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). For the current edition of the FDA-recognized consensus standards referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” This guidance supplements other FDA documents regarding the specific content requirements and recommendations of a premarket notification (510(k)) submission. You should also refer to 21 CFR 807.87 and FDA’s guidance, “Format for Traditional and Abbreviated 510(k)s.”3 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidance describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

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