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U.S. Department of Health and Human Services

Medical Devices

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Description of Sterile Devices in Premarket Notification [510(k)] Submissions Review Template (Accessible Text)

This flowchart depicts guidance documents that should be utilized during the review of sterile devices. For sterile, single-use devices (SUD), use the guidance "Updated 510(k) Sterility Review Guidance K90-1. For reusable devices and non-sterile SUDs to be sterilized once by a health care facility, use the guidance, "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities." For reprocessed SUDs, use the guidance document, "Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single Use Devices." For devices subject to aseptic processing and filtration methods, see relevant guidance. For non-traditional sterilization methods: 1. Refer to Infection Control Devices Branch (INCB) Chief for consideration, and 2. INCB will advise ODE reviewing Division and OC for appropriate action. For "novel non-traditional sterilization methods, use the same as 1. and 2. above. In addition, INCB, the reviewing Division Director, ODE Deputy Director for Science and Regulatory Policy and OC will determine the need for premarket inspection. For 510(k) devices proposed to be sterilized by traditional and non-traditional methods, FDA reviewers should use the following review criteria to evaluate and document the sterilization information.