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  1. Device Advice: Comprehensive 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

Spotlight

Recalls & Alerts

Approvals & Clearances

Contact FDA

301-796-5450

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

10903 New Hampshire Avenue
WO66-5521
Silver Spring, MD 20993