LATEX CONDOM EXPIRATION DATING BASED ON ACCELERATED AGING DATA WOULD BE ALLOWED UNDER PROPOSED RULE; NO 510(k) NEEDED FOR LABELING ADDITION
This article was originally published in The Gray Sheet
FDA would permit latex condom expiration dating of up to five years based on short-term accelerated aging studies under a proposed rule published in the May 24 Federal Register. Upon successful completion of tests in which packaged condoms would be stored at 70C for seven days and at 40-50C for 90 days, manufacturers could label products for a shelf life of up to five years, FDA says.
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