Four ultrasound devices added to third-party review program via FDA final guidance.
This article was originally published in The Gray Sheet
Executive Summary
FDA FINAL 510(k) GUIDANCE ON ULTRASOUND SYSTEMS AND TRANSDUCERS brings to 27 the number of Class II devices eligible for outside scrutiny under the agency's third-party 510(k) review pilot. Although the guidance applies to all ultrasound equipment, the agency's Sept. 30 release of the final version permits FDA to add four specific Class II ultrasound devices to the third-party review program: nonfetal ultrasonic monitors, ultrasonic pulsed doppler imaging systems, ultrasonic pulsed echo imaging systems, and diagnostic ultrasonic transducers.