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FDA GUIDANCE ON 510(k)s FOR DEVICE CHANGES

This article was originally published in The Gray Sheet

Executive Summary

FDA GUIDANCE ON 510(k)s FOR DEVICE CHANGES should focus on the significance of the modification rather than simply on whether a change has occurred, the Health Industry Manufacturers Association says in July 18 comments on FDA's April 8 draft guidance document, "Deciding When to Submit a 510(k) for Changes to an Existing Device." The document, HIMA complains, "focuses mainly on whether a change has occurred, rather than more properly on the significance of the change" (emphasis HIMA's).
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