Condom shelf-life testing on first three lots, in lieu of "random" testing, supported by HIMA.
This article was originally published in The Tan Sheet
Executive Summary
LATEX CONDOM SHELF-LIFE TESTING ON INITIAL THREE LOTS should be adequate for FDA in lieu of testing on three "discrete and random lots" as proposed by the agency, the Health Industry Manufacturers Association said in Aug. 22 comments on FDA's May 24 proposed regs for condom labeling. The proposal 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 Tan Sheet" May 27, In Brief).