June 26, 2019 — 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.

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); and

• Introduces a new transducer element integrity check which applies to all the ultrasound devices covered in the guidance.

On Aug. 22, 2019, the FDA will host a webinar  for device manufacturers and others interested in learning more about this final guidance.

Read the full guidance document here.

For more information: www.fda.gov