> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Ultrasonic Diathermy Devices Policy Clarification
- URL: https://www.fdaweb.com/ultrasonic-diathermy-devices-policy-clarification/
- Published: 2018-04-17T12:00:00.000Z
- Updated: 2026-09-14T23:59:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141233

*Federal Register* notice: FDA has made available a guidance entitled “Policy Clarification and Premarket Notification \[510(k)\] Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff.” The document clarifies FDA’s policy on compliance with applicable performance standards and conformance to International Electrotechnical Commission (IEC) consensus standards for ultrasonic diathermy devices. It also addresses recommended information to provide in 510(k) submissions for such devices. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-04-16/pdf/2018-07824.pdf?ref=fdaweb.com).