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FDA Reuse Policy Demands Data From Both OEMs And Reprocessors

This article was originally published in The Gray Sheet

Executive Summary

FDA's revised policy on reprocessing of disposable medical devices would require manufacturers seeking to label a product as single-use only to submit data demonstrating that it cannot adequately be reprocessed, FDA staffers report.

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FDA Risk Categorization Plan Says SUDs With Narrow Lumens Are High Risk

Reprocessed single-use devices (SUDs) would be considered "high risk" under FDA's proposed categorization scheme if they include inaccessible parts, narrow lumens, rough or porous surfaces, interlocking parts or other features that impede their cleaning, disinfecting or sterilization, according to an agency draft guidance.

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