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FDA home-use HIV test guidance suggests field trials on lay comprehension of labeling.

This article was originally published in The Gray Sheet

Executive Summary

FDA HOME-USE HIV SPECIMEN COLLECTION KIT GUIDANCE RECOMMENDS FIELD TRIALS that examine "lay comprehension of the instructions and educational materials" that accompany the product. The guidance, published by FDA in the Feb. 23 Federal Register, suggests that sponsors of pre-market applications for home-use specimen collection kits for HIV-1 and/or HIV-2 antibody testing should conduct "field trials" in a "population likely to resemble the intended market for the collection kit."
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