Table of Contents
CBER's policies on assay regulation: Definitions of assay performance characteristics
Regulation of In-Vitro Diagnostics (IVD)
IVDs in CBER
Statutes for IVD Regulation
Regulatory Jurisdiction
CBER/FDA licensed/approved HIV tests
General Regulatory Requirements for HIV Tests
Manufacturing consistency means:
Sensitivity (general)
Specificity (general)
Reproducibility
Specific concerns for regulation of HIV drug resistance genotype tests
Special Controls for HIV Drug Resistance Genotype Tests
Special Controls for HIV Drug Resistance Genotype Tests
Concepts being Entertained for the Guidance Document for Resistance Tests
Concepts being Entertained for the Guidance Document for Resistance Tests
Public Contributions to the Guidance Document
Summary
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