DIAGNOSTIC ULTRASOUND 510(k)S COULD INCLUDE THIRD-PARTY CERTIFICATION IN LIEU OF CERTAIN SAFETY DATA, FDA SAYS IN DRAFT REVISED GUIDANCE DOCUMENT
This article was originally published in The Gray Sheet
Executive Summary
Manufacturers of diagnostic ultrasound systems could submit third-party certification of compliance to certain voluntary standards in 510(k)s instead of submitting actual performance data covered by the standards under draft revisions to FDA's guidance document for diagnostic ultrasound systems and transducers.
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