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

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notifications to FDA within 18 months of the issuance of a final SUD enforcement guidance, according to the agency's draft guidance, "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals," released Feb. 8.