News | Ultrasound Imaging | June 27, 2019

New guidance includes needed information for 510(k) submissions, modifications not requiring new submissions and new transducer element integrity check

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

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


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