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The 12%: Diagnostics “Quick Reviews” Make A Mark, FDA Official Says

This article was originally published in The Gray Sheet

Executive Summary

The first month of the diagnostics office’s “triage” pilot program has led to quicker reviews for some 510(k)s, an agency official reports. To qualify for the program's quick-review pathway, a submission must be of high quality and free of certain time-consuming complexities.


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