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In Brief: Hemodialysis component guidance

This article was originally published in The Gray Sheet

Executive Summary

Hemodialysis component guidance: FDA issues final guidance on 510(k)s for hemodialysis water purification components and systems May 30 which incorporates minor clarifications and some additional specifics on data requirements. An initial draft of the document issued in April 1995; a second draft issued in May 1996 ("The Gray Sheet" Oct. 30, 1995, I&W-6). While the guidance is now final, "comments and suggestions may be submitted at any time for agency consideration," the document states...
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