FDA Seeking Comments on Draft Guidance: Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices

Today, the Food and Drug Administration (FDA) released a draft guidance document, "Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices." This draft guidance describes FDA’s proposed recommendations for complying with the performance standard requirements in 21 CFR 1050.10 related to ultrasonic diathermy devices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  Because conformance to certain IEC standards identified in this draft guidance adequately addresses the technical concerns intended to be addressed by the performance standard requirements, once this guidance is finalized, FDA does not intend to consider whether firms who provide a declaration of conformity and indicate conformance to applicable IEC standards also comply with 21 CFR 1050.10.

In addition, this draft guidance document proposes recommendations for information to provide in 510(k) submissions for these ultrasonic diathermy devices.

Comments to this draft guidance should be submitted either electronically or in writing within 60 days of publication in the FEDERAL REGISTER.  Comments can be submitted to http://www.regulations.gov/ under Docket No. FDA-2017-D-4764.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health