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

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."

The average time it takes for FDA to complete a 510(k) review is declining

, which is positive news for device firms. But sponsors still say their submission-by-submission experience varies

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