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Reuse of single-use devices

This article was originally published in The Gray Sheet

Executive Summary

Senate Health Committee Chairman James Jeffords (R-Vt.) and panel member Bill Frist (R-Tenn.) request in a July 2 letter to FDA Commissioner Jane Henney that the agency provide by July 12 an explanation as to the "current activities...being taken by FDA to ensure that all reprocessed single-use devices are safe and effective for their intended use." The senators also ask FDA to explain its "future plans...to address this issue, including a detailed timeline for full implementation." The agency also is requested to specify whether it believes "new legislative authority is necessary for FDA to require" registration of and premarket submissions from device reprocessors. In addition, FDA is asked to supply the "total number" and a "complete list" of reprocessed, single-use devices
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