UPDATE: FDA Affirms Functional Equivalence of DuPont Tyvek

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