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FDA Single-Use Device Reuse Policy Expected To Solidify By Mid-2000

This article was originally published in The Gray Sheet

Executive Summary

FDA's Center for Devices and Radiological Health plans to extend regulatory authority over reprocessing of single use devices (SUDs) by mid-2000.

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FDA Plans Revisions To Guidance For Categorizing SUD Reprocessing Risks

FDA currently intends to reissue by the end of January its scheme for categorizing the risk of reprocessing single-use devices (SUDs) as a level one guidance document, according to staffers.

FDA Plans Revisions To Guidance For Categorizing SUD Reprocessing Risks

FDA currently intends to reissue by the end of January its scheme for categorizing the risk of reprocessing single-use devices (SUDs) as a level one guidance document, according to staffers.

High-Risk Reprocessed SUD List Under Consideration By Device Center

FDA may opt to create a list of reprocessed single-use devices (SUDs) that it considers to be "high" risk, Center for Devices and Radiological Health Office of Compliance Director Larry Spears reported at a Dec. 14 public meeting in Rockville, Maryland.

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