The U.S. Food and Drug Administration (FDA) issued final guidance on the marketing clearance and use of diagnostic ultrasound systems and transducers.
The document offers detailed recommendations for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers, the agency said. It includes the following:
- Recommendations on what should be included in a premarket 510(k) application for diagnostic ultrasound systems and transducers
- The kinds of modifications to a diagnostic ultrasound device for which a new premarket 510(k) application is unnecessary
- A new transducer element integrity check that applies to all the ultrasound devices covered in the guidance
The FDA will host a webinar for device manufacturers that wish to learn more about this final guidance on August 22, 2019, it said.
