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FDA
Issues Draft Guidance to Industry Regarding HIV Drug Resistance
Genotype Assays
The FDA Center for Biologics Evaluation and Research
(CBER) has issued draft guidance to help manufacturers and sponsors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.
This FDA draft document is being distributed for comment only, and
is not intended for implementation at this time.
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.
An HIV Drug
Resistance Genotype Assay is an in vitro diagnostic device (IVD)
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
full text of FDA's draft guidance
Interested
persons may submit written comments on the document to:
Dockets Management
Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane,
rm. 1061 Rockville, MD 20852
Comments may
also be submitted electronically to
http://www.fda.gov/dockets/ecomments
Please submit
written or electronic comments by October 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 the 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, 301-827- 6210.
9/12/01
Source
http://www.fda.gov/cber/guidelines.htm
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