U.S. FDA affirms functional equivalence of Tyvek from DuPont

DuPont Protection Technologies (DuPont) received notification from the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) affirming the functional equivalence of transition Tyvek to current Tyvek for sterile medical packaging.  

This decision marks a significant milestone in the DuPont Tyvek Medical Packaging Transition Project (MPTP), a multi-year undertaking to help the medical packaging industry transition to Tyvek manufactured using updated flash spinning equipment and technology, and signals the beginning of commercial sales of the transitioned advanced material. Health Canada also has issued their guidance on filing a modified license amendment for transition Tyvek in Canada.

With affirmation of functional equivalence, the U.S. FDA states that it is not necessary for Medical Device Manufacturers to file amended 510(k)s or PMAs when substituting transition Tyvek for current Tyvek during the manufacture of approved medical devices in most cases. Commercial sales of transition Tyvek can now begin in October 2015, as previously announced.  Recognizing that some medical device manufacturers, especially those with Class III devices sold in Europe, are awaiting Notified Body approvals, DuPont is increasing the availability of current Tyvek® and will continue to produce this material on a schedule that is aligned with the needs of our stakeholders.

Announced in 2011, the MPTP is a multi-year investment by DuPont of more than $30 million to transition Tyvek 1073B and Tyvek 1059B to the latest flash-spun technology and equipment to help ensure the continuity and flexibility of future supply into medical and pharmaceutical packaging applications worldwide. DuPont is working closely with Sterile Packaging Manufacturers, Medical Device Manufacturers, testing laboratories and regulatory bodies around the world throughout every phase of this project.

For more than 40 years, Tyvek has helped to protect the health of millions of patients worldwide and to reduce costs in the healthcare setting by maintaining sterility of medical devices and supplies to the point of use. Recognized as a standard of excellence in healthcare packaging, this advanced material is used in virtually every form of sterile medical packaging, as well as a wide variety of pharmaceutical packaging applications.