FDA Releases Final Guidance for Marketing Ultrasound Devices

June 26, 2019

The FDA issued final guidance for devicemakers looking to obtain 510(k) clearance for diagnostic ultrasound systems and probes.

The guidance, which supersedes draft guidance published in October 2017, recommends regulatory approaches for certain diagnostic ultrasound devices — including ultrasonic pulsed doppler imaging systems; ultrasonic pulsed echo imaging systems; diagnostic ultrasonic transducers, echocardiographs; home uterine activity monitors; and nonfetal ultrasonic monitors, among others.

Certain modifications made to diagnostic ultrasound devices won’t be subject to premarket notification requirements, the guidance says. It also offers examples of ultrasound device sponsors that made unnecessary 510(k) submissions in the past.

Devices that have added continuous-wave and pulsed-wave doppler interrogation methods will be exempt from premarket notification requirements. Devices that have added a B-mode noise reduction filter for use in general imaging will also be exempted.

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