Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Resumo

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; Draft Guidance for Industry and Food and Drug Administration Staff." This draft guidance provides detailed information recommended for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. This draft guidance is not final nor is it in effect at this time.