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SUDs (single-use-devices) manufacturers upset over FDA product safety classifications

This article was originally published in Clinica

Executive Summary

Reprocessors and original equipment manufacturers remain deeply divided over the FDA's efforts to regulate the reuse of single-use devices (SUDs). But somewhat ironically, it is not the reprocessors but the disposable device manufacturers who are displeased at present, believing the agency simply has not gone far enough to stress the safety differences between the one-time use of a disposable and a reused product.

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