December 11, 2017

[FEATURED] New 510(k) Modifications Guidance May Prompt New Submissions

US FDA has made at least nine changes releasing a final 510(k) modifications guidance on Oct. 24. This new guidance showcases useful flowcharts to help device sponsors determine when a new 510(k) submission will be needed for their product. The FDA states that “when evaluating a change in device and the need for a subsequent new 510(k) that requires an evaluation by agency staff, the agency ‘shall only require the “minimum required information” necessary to support a determination of substantial equivalence.’ “

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