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FDA to re-issue reprocessor guidance

This article was originally published in The Gray Sheet

Executive Summary

CDRH plans to address question 22 of its July 2003 510(k) data validation guidance for single-use device reprocessor submissions in a revised document to be released within the next few weeks. The question asks: "How long will FDA take to review supplemental validation submissions?" The document will specify time frames and procedures for reviewing the data. The original Level One guidance was required under MDUFMA...
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