Business · 02/10/2017

FDA Releases Draft Guidance for Marketing Clearance of Diagnostic Ultrasound Systems and Transducers

The Food and Drug Administration (FDA) has released a draft guidance document titled "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; Draft Guidance for Industry and Food and Drug Administration Staff," which provides recommendations for manufacturers seeking clearance to market diagnostic ultrasound systems and transducers. The document is not yet finalized and is currently available for review by industry and FDA staff.