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Reuse of single-use devices

This article was originally published in The Gray Sheet

Executive Summary

Association of Disposable Device Manufacturers submits simulated direct final rule to FDA that would require reprocessors to comply with existing premarket regulations, rather than follow the separate three-tiered classification system outlined in FDA's proposed strategy, issued Nov. 2 (1"The Gray Sheet" Nov. 8, p. 3). While FDA would exempt reprocessed SUDs deemed "low-risk" from premarket requirements, ADDM maintains that makers of all reprocessed Class I and Class II SUDs should either be required to submit 510(k)s or file petitions for 510(k) exemption. ADDM's mock reg also would shorten FDA's proposed grace period for reprocessors - requiring PMAs for reprocessed Class III SUDs immediately, 510(k)s for Class II devices in six months, and for Class I devices in nine months

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