CLIA (Clinical Laboratory Improvement Amendments) 5
- COVID-19 Testing Policy: Validation Requirements and Recommendations for Diagnostic and Serology Tests
- Blood Glucose Monitoring Systems for Prescription Point-of-Care Use - Performance Standards and Technical Requirements
- Dual 510k and CLIA Waiver by Application for In Vitro Diagnostic Tests
- CLIA Waiver Applications for In Vitro Diagnostic Devices - Demonstrating Simplicity and Insignificant Risk of Erroneous Results
- Administrative Procedures for CLIA Categorization of In Vitro Diagnostic Tests