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U.S. Department of Health and Human Services

Medical Devices

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OIR Guidance

We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within guidance documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title.  Note that the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) has been reorganized as the Office of In Vitro Diagnostics and Radiological Health (OIR).


OIR (formerly OIVD) Guidance Documents