IVD Regulatory Assistance
This page links to information on how the Office of In Vitro Diagnostic Devices Evaluation and Safety (OIVD) regulates devices.
OIVD Regulatory Resources
OIR 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 Diagnostics and Radiological Health Health Hazard Evaluation Form
- Indications for Use Form