FDA: Transducer Test A Key Element In Ultrasound Guidance

Past adverse events prompted the US Food and Drug Administration to recommend additional transducer checks in a recent ultrasound guidance document, an agency official said during a recent webinar.

Shahram Vaezy, a biomedical engineer in the FDA’s Center for Devices and Radiological Health (CDRH), discussed “Marketing Clearance of Diagnostic Ultrasound Systems and Transducers” during the Aug. 22 session. The guidance document is notable for dropping 510(k) requirements for many modifications to ultrasound devices