In an announcement issued by the Food and Drug Administration (“FDA” or the “agency”) on October 2, 2015, the agency has determined that the performance of the new (Transition) Tyvek® material is functionally equivalent to existing (Legacy) Tyvek® material and therefore, it is not necessary for medical device manufacturers to submit a new 510(k) Notice or PMA supplement for the change based on the upgraded manufacturing process of the Tyvek® material. FDA made this determination based on a review of DuPont’s Device Master File (MAF) #1920, which includes several amendments from June 2 to August 10, 2015, and testing as outlined in the “Protocol for Transition of the Medical Device Industry to Tyvek® Manufactured Using an Upgraded Spinning Process.” Tyvek® is used to fabricate sterile barrier systems for an array of medical devices. The Transition Tyvek® is available in both coated (1073B) and uncoated (1059B) styles.
While FDA has determined functional equivalence between the Tyvek® materials, there is an expectation that Medical Device manufacturers perform the following activities for the new (Transition) Tyvek® material styles coated (1073B) and uncoated (1059B) in accordance with the agency’s device Quality System Regulation (21 CFR part 820).
- Conduct a Risk Analysis to determine if a premarket submission is needed due to a change in risks (e.g., for IVDs – change in performance, cut-offs).
- Implement change control procedures in accordance with the Quality System Regulation, including, but not limited to, evaluation of the impact of this change on packaging and sterilization (if indicated) processes.
- Document activities associated with this change in accordance with the Quality System regulation, including but not limited to, updating the Device Master Record (DMR) and the rationale for acceptance of Transition Tyvek®.
For additional information see DuPont’s website for various supporting transitional information and reference documents:WWW.AREYOUREADY.TYVEK.COM.
Also, see letter from FDA (Jeffrey Shuren, M.D., J.D.) to DuPont.