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HOME-USE HIV TEST SAMPLE COLLECTION KITS: FDA EVALUATION POLICY

This article was originally published in The Tan Sheet

Executive Summary

HOME-USE HIV TEST SAMPLE COLLECTION KITS: FDA EVALUATION POLICY will be reviewed by the agency's Blood Products Advisory Panel at a June 22 meeting. In a June 9 Federal Register notice announcing changes to the panel's agenda for its June 21-22 meeting; FDA said it will "reexamine the approach described" in earlier policy statements published in 1989 and 1990 "to evaluate the safety and effectiveness of [sample] collection kits," specifically those used for detecting HIV infection.
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