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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Opened but unused SUDs: Comments on hospital practices associated with opened but unused single use devices (SUDs) are due by Nov. 26. Specific questions posed in the 1Aug. 28 notice on opened but unused SUDs include: what SUDs are typically resterilized because they are open but unused; how hospitals decide when an opened but unused SUD is contaminated; and whether hospitals have standard operating procedures for such determinations. The agency says it is seeking the information as part of a review of its policy on opened but unused SUDs, which are defined as single-use disposable devices that have not been used on a patient but whose sterility is in question. FDA is seeking comments from hospitals, original equipment manufacturers, reprocessors, professional organizations and other interested parties...

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