Marketing Clearance of Diagnostic Ultrasound Systems and Transducers

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers

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

Today, the U.S. Food and Drug Administration (FDA) issued the final guidance: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.  This final guidance provides detailed recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. Read the Guidance

Facts about the final guidance This final guidance: Provides recommendations on information that should be included in a premarket notification (510(k) submission) for diagnostic ultrasound systems and transducers. Describes the types of modifications to a diagnostic ultrasound device for which the FDA does not intend to enforce the requirement to submit a new premarket notification (510(k) submission). Introduces a new transducer element integrity check which applies to all the ultrasound devices covered in the guidance. Upcoming webinar on this guidance On August 22, 2019, the FDA will host a webinar  for device manufacturers and others interested in learning more about this final guidance. Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education.