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CURRENTLY MARKETED HEMODIALYZERS MAY RELY ON EXISTING REUSE DATA

This article was originally published in The Gray Sheet

Executive Summary

CURRENTLY MARKETED HEMODIALYZERS MAY RELY ON EXISTING REUSE DATA to establish the effects of reprocessing on device functioning, FDA says in a revised draft guidance released earlier this year on testing and labeling for hemodialyzer reuse. Unlike earlier versions of the document, the latest draft draws a distinction between new and previously approved hemodialyzers and provides a more flexible approach to gathering data for currently marketed products.
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