IVD Regulatory Assistance

This page links to information on how the Office of Health Technology 7: Office of In Vitro Diagnostics (OHT7) regulates devices.

OHT7 Regulatory Resources

• Manufacturer Certification Programs
• Suggested Analytical Testing Protocol for In Vitro Diagnostic Devices Manufactured with Heparin Contaminated With Oversulfated Chondroitin Sulfate
• In Vitro Diagnostic Device Labeling Requirements
• Device Advice: Comprehensive Regulatory Assistance
• OHT7: Office of In Vitro Diagnostics

Spotlight

• In Vitro Diagnostics

Recalls & Alerts

• In Vitro Diagnostic Device Recalls Database

Approvals & Clearances

• Find All FDA-Approved Home and Lab Tests
• Find All In Vitro Diagnostic Products and Decision Summaries Since November 2003
• Search the CLIA Database

Contact FDA

301-796-5450

Office of Health Technology 7: Office of In Vitro Diagnostics
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO66-5521
Silver Spring, MD 20993