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FDA Tries To Get 'Smart' In Standardizing 510(k) Reviews

This article was originally published in The Gray Sheet

Executive Summary

The agency's device center is in the midst of adopting a "Smart" 510(k) template to improve reviewer-to-reviewer consistency and speed up the learning curve for new reviewers. It is part of a broader IT push at the center to further standardize industry submissions and how they are reviewed, the Office of Device Evaluation's Barbara Zimmerman tells "The Gray Sheet."

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