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Germicide testing on surrogate devices supported by Olympus in comments on draft guidance.

This article was originally published in The Gray Sheet

Executive Summary

LIQUID CHEMICAL GERMICIDE TESTING WITH DEVICE SURROGATES SUPPORTED BY OLYMPUS in Aug. 20 comments to FDA. Commenting on FDA's December 1996 draft guidance for germicide 510(k)s, endoscope manufacturer Olympus America, Inc. says that "surrogates would enhance the standardization of simulated use testing by minimizing potential procedural variations and increasing the troubleshooting capability of the investigators."
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