- Federal Register Notice: Draft Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays;’’ Availability
- Final Guidance Document: Guidance for Industry Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay
The American Society for Microbiology (ASM) is the largest educational, professional, and scientific society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents more than 40,000 microbiologists, including scientists and science administrators in academic, industry and government institutions working in a variety of areas, including biomedical, environmental, and clinical microbiology. In response to the notice announcing the availability of the draft document, "Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays: Special Controls, published in the Federal Registeron, August 29, 2001, the ASM provides the following comments:
The interpretation algorithm should be documented with references to the supporting literature or other data for all mutations including those listed in Tables A and B.This is important because clinical trials correlating outcome with the presence or absence of HIV resistance mutations are the best measure of the clinical significance of in vitro testing.
There needs to be an independent method to arbitrate the validity of the mutations detected by the genotypic assay.Certain well-characterized strains tested by an independent method could serve as control strains.
We appreciate the opportunity to comment and would be pleased to respond to any questions or requests for additional information.