CBER's policies on assay regulation: Definitions of assay performance characteristics

7/25/00


Click here to start


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

Author: CBER