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"Stratified" 510(k) Review Tracks Might Result From CDRH Resource Crunch

This article was originally published in The Gray Sheet

Executive Summary

FDA's Center for Devices and Radiological Health is considering whether or not to "stratify" 510(k) submissions into "high-priority" and "low-priority" categories that would have different review timeframes, CDRH Director David Feigal said.

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