Tyvek® Rx: December 2015
It’s official! On October 1, 2015, the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) affirmed that Tyvek® produced on DuPont’s newer manufacturing lines is functionally equivalent to Tyvek® produced on the older lines.
This decision marks a significant milestone in the DuPont™ Tyvek® Medical Packaging Transition Project (MPTP) and signals the beginning of commercial sales of transition Tyvek®.
Another important milestone was reached the previous day when Health Canada issued guidance on filing a modified licence amendment for transition Tyvek® in Canada.
These breaking news items and much more were discussed by members of the DuPont Medical and Pharmaceutical Protection Team during the October 6, 2015, webinar titled: “Major Milestones Achieved—MPTP Enters Next Phase.”
Michael H. Scholla, Ph.D., Global Director, Regulatory and Standards; Medical Packaging Fellow; Bruce A. Yost, Ph.D., Global Technical Director; Karen Polkinghorne, Packaging Engineer and MDM Specialist; and Margaret (Meg) Pyers, Global Marketing Director were the featured speakers.
Following the presentation, the speakers responded to questions submitted by many of the nearly 500 attendees of this global event.
Highlights from the webinar include:
- October 1, 2015, letter from CDRH at U.S. FDA affirming functional equivalence
- Summary of September 30, 2015, guidance from Health Canada
- Tips for submissions to Notified Bodies
- Regulatory update from Japan that no action is required based upon new laws
- MPTP interim test results after 7- and 10-year accelerated aging
- Helpful hints for MDMs
- Updated DuPont commercialization plan, including news that DuPont is extending the availability of legacy Tyvek® through June 2016 in response to customer requests
If you were unable to attend this live event, we encourage you to view this webinar on-demand. You can also view and download the slides used during this event, as well as other MPTP documents, at www.areyouready.tyvek.com.