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Industry expresses concern over US FDA guideline on device changes needing new 510(k)s

This article was originally published in SRA

Executive Summary

US medtech industry association AdvaMed warns that the number of pre-market notification applications that are submitted for device modifications could rise by 300-500% if a recent draft guideline by the Food and Drug Administration is implemented1. The association is concerned that the proposals in the draft document would result in the submission of more applications than the FDA can handle, resulting in unnecessary delays in the processing of submissions for new technologies and in patient access to modified devices.

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