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Reprocessed single-use devices

This article was originally published in The Gray Sheet

Executive Summary

FDA will allow 30 days for SUD reprocessors to respond to additional-information letters concerning 510(k) Supplemental Validation Submissions, but will not grant time extensions, according to 1revised guidance issued May 27. "Manufacturers should have this validation information readily available since the reprocessed device(s) are currently marketed and such data should have been developed and maintained" under QS requirements, FDA reasons. Original 510(k) applicants, by contrast, are allowed 90-day extensions to respond to AI letters (2"The Gray Sheet" May 24, 2004, p. 10). The reprocessor 510(k) data validation guidance supersedes a July 2003 document...
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