We are writing to notify you that on the basis of data submitted by DuPont, including testing of the functional performance of the product during medical device sterilization and maintenance of package integrity over time, the FDA has determined that DuPont’s new (Transition) Tyvek products are functionally equivalent to existing (Legacy) Tyvek products. Tyvek is used to fabricate sterile barrier systems for an array of medical devices. The new product is manufactured using an upgraded spinning process.
· Document activities associated with this change in accordance with the Quality System regulation, including but not limited to, updating the Device Master Record and the rationale for acceptance of Transition Tyvek.
Food and Drug Administration Center for Devices and Radiological Health