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Medical Devices
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In Vitro Diagnostics
In vitro diagnostics are tests that can detect diseases, conditions, or infections. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home.
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News & Events
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OIVD Regulatory Resources
- FDA eSubmitter
- Overview of IVD Regulation
- Clinical Laboratory Improvement Amendments (CLIA)
- OIVD Guidance
- Device Advice: Device Regulation and Guidance
- In Vitro Diagnostic Device Labeling Requirements
- Office of In Vitro Diagnostic Device Evaluation and Safety
- Manufacturer Certification Programs
- Suggested Analytical Testing Protocol for In Vitro Diagnostic Devices Manufactured with Heparin Contaminated With Oversulfated Chondroitin Sulfate
- Health Hazard Evaluation Form
- Indications for Use Form
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Spotlight
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Approvals & Clearances
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Contact Us
CDRH-Office of In Vitro Diagnostic Device Evaluation and Safety
- 301-796-5450
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO66-5521
Silver Spring, MD 20993
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