Condom shelf-life testing on first three lots should be allowed by FDA -- HIMA comments.
This article was originally published in The Gray Sheet
LATEX CONDOM SHELF-LIFE TESTING ON FIRST THREE LOTS SHOULD BE ALLOWED under FDA rules on condom labeling and expiration dating, the Health Industry Manufacturers Association says in Aug. 22 comments to FDA. Commenting on a May 24 FDA proposed rule, HIMA says the reg should allow testing on three "typical" lots rather than three "discrete and random lots" as proposed by FDA. The proposed rule would allow latex condom expiration dating of up to five years based on short-term accelerated aging studies and follow-up real-time testing ("The Gray Sheet" June 3, p. 10).
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