News In Brief
This article was originally published in The Gray Sheet
Industry urges restraint at 510(k) modifications meeting. User fee sequestration unaddressed at House Appropriations Committee markup. More news
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As FDA prepares a report due to Congress in January on its policy for determining when a modified device needs a new 510(k), industry representatives say major changes are not necessary to the current process. But they suggest some tweaks that could make things work more smoothly.