US FDA: Functional Equivalence for Reformulated Sterilization Product from DuPont
US medical device regulators have notified registrants that production changes to a commonly used sterilization product from DuPont will likely not warrant new 510(k) or Premarket Notification (PMA) filings from device manufacturers.
Known as Tyvek®, the product is used by many manufacturers in their sterilization and packaging processes for their devices. After DuPont changed its production process for Tyvek®, Health Canada announced in 2014 that the regulator would require some manufacturers licensed to sell their products in Canada to file significant change amendments reflecting use of the reformulated sterilized packaging material.
Now that DuPont has made testing data pertaining to its new version of Tyvek® available to regulators, the US Food and Drug Administration has taken what seems to be a less stringent approach to the issue. The agency’s notice to industry states that submitting new premarket notifications or PMA applications on the basis of switching between old and new versions of Tyvek® will not be necessary barring any specific regulatory requests or notices.
However, the FDA does advise US market registrants to determine through the following steps whether any obligations they have under 21 CFR Part 820 quality system regulations may need to be addressed:
Running a risk analysis to see whether a new premarket submission is warranted because of a change in a device’s risk characteristics
Implementing change control procedures to determine the impact of the new Tyvek® formulation on packaging and sterilization processes
Documenting all processes undertaken to address these changes based on Quality System Regulation requirements
“The FDA has notified industry that they have determined that DuPont’s new Tyvek products are functionally equivalent, but each manufacturer should still determine what if any impact this may have on their specific product packaging or sterilization cycle,” says Richard Vincins, Vice President of Quality Assurance Consulting at Emergo.
“We recommend that companies perform risk assessments, evaluate changes to their packaging requirements and properly document their reviews in accordance with their quality system requirements in order to justify acceptance of this change.”