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: Comprehensive Regulatory Assistance Office of In Vitro Diagnostic Device Evaluation and Safety Health Hazard Evaluation Form Indications for Use Form
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Contact FDA
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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