IVD Regulatory Assistance
This page links to information on how the Office of Health Technology 7: Office of In Vitro Diagnostics and Radiological Health (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 and Radiological Health, Office of Product Evaluation and Quality
Spotlight
Recalls & Alerts
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 and Radiological Health
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO66-5521
Silver Spring, MD 20993