FDA Accepts Preliminary Study Results for Tyvek

DuPont Nonwovens is upgrading the manufacturing process for Tyvek. To minimize the systems costs associated with this transition for the medical packaging industry, DuPont developed an extensive, two-stage test protocol in conjunction with FDA, sterile packaging manufacturers, medical device manufacturers, and HIMA.

The first stage, known as the Preliminary Study, compared Tyvek 1073B produced using the current process in Richmond, VA., to Tyvek 1073B produced in Luxembourg. The purpose of this study was to validate the test protocol.

Following FDA's review and acceptance of the Preliminary Study results, the agency issued a guidance letter to the industry stating that the manufacturing process does not result in a significant change to the functional performance of Tyvek during medical device sterilization and the maintenance of package integrity over time.

As a result, FDA recommends that it is not necessary for device manufacturers to file amended 510ks or amended PMAs when Tyvek produced in one location is substituted for Tyvek produced in another location during the manufacture of approved medical devices. However, FDA notes that the change in the source of Tyvek should be documented in each applicable device record. This recommendation applies to both coated and uncoated Tyvek.

FDA's acceptance marks the completion of the first stage of the transition plan. The final stage will be a Full Study comparing Tyvek 1073B produced using the current process to Tyvek 1073B produced using the upgraded process. The Full Study is expected to begin by the year 2000.

To obtain a copy of the summary of the Preliminary Study, call DuPont Nonwovens at (800) 448-9835. More details about the transition plan, as well as additional information about the Preliminary Study results, are contained in a videotape and handout sheet, which are also available.