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Medical Devices
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IVD Regulatory Assistance
This page links to information on how the Office of In Vitro Diagnostic Devices Evaluation and Safety (OIVD) regulates devices.
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OIVD Regulatory Resources
- OIVD Guidance
- 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: Device Regulation and Guidance
- Office of In Vitro Diagnostic Device Evaluation and Safety
- Health Hazard Evaluation Form
- Indications for Use Form
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Approvals & Clearances
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Contact Us
- 301-796-5450
CDRH-Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO66-5521
Silver Spring, MD 20993
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