FDA notifications

In vitro drug resistance genotype assays

(Editor’s note: Beginning in this issue, AIDS Alert will print HIV drug notices and other information issued by the Food and Drug Administration.)

In September 2001, the Food and Drug Administration (FDA) released a notice of draft guidance for industry with pre-market notifications for in vitro HIV drug resistance genotype assays. The guidance is available on the Internet at this address: www.fda.gov/OHRMS/DOCKETS/98fr/010286gd.pdf. An HIV Drug Resistance Genotype Assay is an in vitro diagnostic device intended for clinical laboratories to use in detecting HIV genomic mutations that confer resistance to specific anti-retroviral drugs, as an aid in monitoring and treating HIV infection.

The FDA Center for Biologics Evaluation and Research (CBER) has issued this draft guidance to help manufacturers and sponsors of HIV Drug Resistance Assays comply with the requirement of special controls for class II devices, if the HIV Drug Resistance Assay devices are reclassified from Class III.

Devices must comply with guidance

Designation of this guidance document as a special control would mean that sponsors and manufacturers must establish that their device complies with either the specific recommendations of this guidance or some alternative control that provides equivalent assurances of safety and effectiveness [§513(f) (21 U.S.C 360c(f)]. The guidance is intended to help ensure the production of standardized, reliable, and reproducible tests for detecting HIV mutations known to be associated with HIV drug resistance. This draft document is being distributed for comment only, and is not intended for implementation at this time.

Interested people may submit written comments on the document to: Dockets Management Branch (HFA-305) Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may also be submitted electronically to www.fda.gov/dockets/ecomments.

Submit written or electronic comments by Oct. 29, 2001, to ensure consideration in preparation of the final document. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments should be identified with docket number 01D-0286. For further information, contact: Nathaniel L. Geary, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Telephone: (301) 827-6210.

FDA/CBER guidance documents are on the web at www.fda.gov/cber/guidelines.htm.