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Low-Risk SUD 510(k)s Due 18 Months After Final Enforcement Guidance

This article was originally published in The Gray Sheet

Executive Summary

Hospitals and third party reprocessors of single-use devices (SUDs) classified as low risk must submit premarket notifications to FDA within 18 months of the issuance of a final SUD enforcement guidance, according to the agency's draft guidance, "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals," released Feb. 8.

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