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GUIDANCE DOCUMENT

Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices Guidance for Industry and Food and Drug Administration Staff February 2023

Download the Final Guidance Document
Final
Docket Number:
FDA-2017-D-4764
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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). 

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-4764.

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