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# Draft Guide on Diagnostic Ultrasound Systems and Transducers
- URL: https://www.fdaweb.com/draft-guide-on-diagnostic-ultrasound-systems-and-transducers/
- Published: 2017-10-02T12:00:00.000Z
- Updated: 2026-09-14T22:53:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139751

FDA has made available a draft guidance on “Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.” The document provides detailed recommendations for device makers seeking marketing clearance of such devices, and for deciding when a device modification to a diagnostic ultrasound device can be made without the need for submission of a new 510(k). It notes that device sponsors who comply with applicable premarket notification requirements will continue to be exempt from the Electronic Product Radiation Control reporting requirements in 21 CFR 1002.12 for diagnostic ultrasound devices. To view the guidance, click [here](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM578118.pdf?ref=fdaweb.com).