Medical Devices

Office of In Vitro Diagnostics and Radiological Health Final Guidance

This page lists final guidance documents developed by CDRH’s Office of In Vitro Diagnostics and Radiological Health. For a list of current draft guidance documents, please see the Draft Guidance page.

Some Web links (URLs) embedded within guidance documents are no longer valid.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) Final Guidance Documents

Page Last Updated: 12/18/2014
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