DuPont receives FDA affirmation of functional equivalence of transition Tyvek

Pharmaceutical & Medical Packaging News staff

FDA’s Center for Devices and Radiological Health (CDRH) has affirmed the functional equivalence of transition Tyvek to current Tyvek for sterile medical packaging, DuPont Protection Technologies (DuPont) is reporting in a news release issued today. The notification from FDA represents what the company calls “a significant milestone in the DuPont Tyvek Medical Packaging Transition Project (MPTP).” The multiple-year program has been helping medical device manufacturers (MDMs) prepare for the transition to Tyvek 1073B and Tyvek 1059B manufactured with DuPont’s latest flash-spinning technology on production lines at its Richmond, VA, and Luxembourg facilities.

The MPTP team will discuss the latest news tomorrow (October 6) in the Webcast “Major Milestones Achieved — MPTP Enters Next Phase.” The team will also share DuPont’s plans for commercialization and ongoing support along with MPTP interim test results after 7- and 10-year accelerated aging. It will also offer tips for submissions to notified bodies. 

With affirmation of functional equivalence, the U.S. FDA states that it is not necessary for MDMs 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, DuPont reports in the news release.

According to an FDA news bulletin, "absent a specific request or notice from FDA or a risk analysis to the contrary, it is not necessary for medical device manufacturers to submit a new 510(k) or PMA supplement for a change solely in packaging from the Legacy Tyvek to the Transition Tyvek manufactured using the upgraded spinning process, including both coated and uncoated styles 1073B and 1059B."

DuPont also reports that Health Canada has issued its guidance "on filing a modified license amendment for transition Tyvek in Canada." 

DuPont is also announcing that commercial sales of transition Tyvek can begin this month.

“Receiving FDA affirmation of functional equivalence and Health Canada guidance is the culmination of years of preparation, collaboration, and execution of a meticulous process,” states Michael H. Scholla, Ph.D., global director, Regulatory and Standards, DuPont Protection Technologies, in the news release. “We would like to thank the FDA, Health Canada, and all those who have participated in this process; it is a great demonstration of the power of an effective supplier-industry-government collaboration.” 

Throughout the MPTP, DuPont has worked closely with MDMs, sterile packaging manufacturers, testing laboratories, and regulatory bodies around the world.  

“We have worked successfully with DuPont for many years,” states Nick Fotis, global packaging director, Cardinal Health, in the news release. “Their handling of this complex regulatory challenge – the way they facilitated the challenging transition for their customers, coordinating with regulatory agencies around the world – is testament to why DuPont is a trusted partner in the medical packaging industry. DuPont has been a leader in our industry for many years and their collaboration with customers across the supply chain and throughout this complex global regulatory process, from package design and testing to data sharing and communications is why we choose DuPont Tyvek.”

MDMs can find a copy of the U.S. FDA letter affirming functional equivalence, as well as other regulatory information, Industry Summary Reports, and the latest MPTP testing results at www.areyouready.tyvek.com. DuPont will continue to post Industry Summary Reports on its Web site, and package testing will continue to examine real-time and accelerated aging time points. Following completion of each study time point, confidential regulatory reports will be issued to the U.S. FDA, Health Canada, and five Notified Bodies in Europe, the company states.

DuPont is also increasing the availability of current Tyvek, explaining that some MDMs, especially those with Class III devices sold in Europe, are awaiting Notified Body approvals. The company states it “will continue to produce this material on a schedule that is aligned with the needs of our stakeholders.”