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Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices Guidance for Industry and Food and Drug Administration Staff April 2018

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.

Submit Comments

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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