FDA Releases Final Guidance on Marketing Clearance of Diagnostic Ultrasound Systems and Transducers

Summary

The Food and Drug Administration (FDA) has released a final guidance document titled "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," which provides recommendations for manufacturers seeking clearance to market diagnostic ultrasound systems and transducers. The guidance also outlines the types of modifications that the FDA will not require a new premarket notification (510(k)) for.