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  1. Medical Devices

IVD Regulatory Assistance

IVD Regulatory Assistance

This page links to information on how the Office of In Vitro Diagnostic and Radiological Health (OIR) regulates devices.

OIVD Regulatory Resources


Recalls & Alerts

Approvals & Clearances

Contact FDA


CDRH-Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health

10903 New Hampshire Avenue
Silver Spring, MD 20993