US FDA's August draft guidance on 510(k) modifications confusingly intermixes what are supposed to be two distinct factors for deciding whether a new submission is necessary, industry stakeholders say. Companies also call for the agency to update its language in the draft to remove the suggestion that manufacturers must repeatedly assess and document every incremental change to a 510(k)-cleared device to evaluate the cumulative impact of recent changes.
The 510(k) modifications draft, released Aug. 5, stressed that FDA wants device sponsors to complete risk-based assessments on changes they make to devices that may involve safety improvements, labeling, technology...
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