510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device

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In late July 2011, The FDA published a draft document of “510 (k) Device Modifications: Deciding When to Submit a 510 (k) for a Change to an Existing Device”. This draft updates FDA’s current position on when a modification to an existing medical device would trigger the requirement to submit a new 510(k) premarket notification.. When final, this guidance will supersede the 1997 “Deciding When to Submit a 510 (k) for a Change to an Existing 510(k)” guidance.The guidance has been updated to address issues associated with software and other rapidly changing technologies, and to provide greater clarity about changes that do not trigger the need for a new premarket submission.The types of modifications addressed include manufacturing process changes, labeling changes, technology or performance specification changes, and material changes.

Access the full draft guidance here.