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DUPONT SUBMITTING INDUSTRY-WIDE STUDY PROTOCOL FOR UPGRADED TYVEK

This article was originally published in The Gray Sheet

Executive Summary

DUPONT SUBMITTING INDUSTRY-WIDE STUDY PROTOCOL FOR UPGRADED TYVEK to FDA in the third quarter of this year, Michael Scholla, senior research microbiologist and regulatory and standards manager for DuPont Tyvek, told HIMA's "Sterilization 2000" conference April 27. DuPont is planning to introduce the upgraded polyethylene material, which is used in medical device packaging, in 1997. The study is intended to demonstrate that the functionality of the upgraded material is not significantly different from the current Tyvek so that manufacturers using the product will not need to submit 510(k)s or premarket approval application supplements covering the change.
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