B
This is a BIG deal, but it appears that DuPont is doing everything they can to assure the transition will be painless for its customers and those downstream. They are working directly with FDA, already garnering their approval for a transition protocol. Based on DuPont and FDA statements, if DuPont's testing goes according to plan, a device manufacturer who currently uses 1073B or 1059B Tyvek will not need to submit a 510(k) or PMA for the change with respect to their device. FDA implies, and DuPont promotes, that medical device manufacturers will only need to put a note to file in their DMR indicating they are using the new equivalent 1073B or 1059B Tyvek in place of the previous 1073B or 1059B. DuPont indicates that the "1073B" and "1059B" style designations will not change, and the revised products will be functionally equivalent to the original versions.
DuPont is posting information to this website as the project progresses: medicalpackaging.dupont.com . Information is currently found using a link found under the title, "DuPont™ Tyvek® in 2012 and Beyond."
DuPont is posting information to this website as the project progresses: medicalpackaging.dupont.com . Information is currently found using a link found under the title, "DuPont™ Tyvek® in 2012 and Beyond."
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