In a move with potential implications for makers of medical devices, DuPont is changing the manufacturing process for Tyvek, a high-density, polyethylene material widely used in the packaging of such devices.
DuPont says it's working with the U.S. Food and Drug Administration to ensure the transition does not complicate the clearance process for medical devices.
In a document explaining the transition, the company says its analysis of the new manufacturing process shows that the Tyvek made the new way "does not represent a significant change in functional performance."
If the FDA agrees, "it would issue guidance indicating that medical devices manufacturers would not be required to file amended 510(k)s or premarket approvals (PMAs) for existing devices because the transition represents a merge, or lot, change," according to DuPont.
Over the course of the transition, the FDA will review data generated by third parties which will show whether the new Tyvek is "functionally equivalent."
DuPont is transitioning the Tyvek 1073B and the 1059B styles to new manufacturing lines that use a flash-spinning technology, which the company says allows for greater capacity.
The Tyvek Asuron and Tyvek 2FS styles won't be affected by this as they are already manufactured using this technology. DuPont says it also shared the transition plan with global regulatory authorities and expects "they will take the same position as the FDA."
The company says it expects the new Tyvek to be available by late 2012 for new devices and in 2014 for existing devices