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No More 510(k)s For Certain Ultrasound Diagnostic-Makers

Ultrasound diagnostic devices that already have a 510(k) won't have to be resubmitted for clearance following modifications if they meet all 10 requirements set forth in an updated US FDA guidance.

Patient with orthopedist doctor in his office. Knee sonography. - Image

The US Food and Drug Administration will use its regulatory discretion to not require all makers of ultrasound diagnostic devices to submit 510(k) applications for certain types of modifications to their products. The agency lists requirements manufacturers would have to meet to skip the process in an updated guidance.

On 26 June, the FDA published the revised final guidance “Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.” The document provides updated recommendations from the agency on what information...

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