U.S. FDA Affirms Functional Equivalence of DuPont™ Tyvek®
WILMINGTON, Del., Oct. 5, 2015 – Today, DuPont Protection Technologies (DuPont) received notification from the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) affirming the functional equivalence of transition Tyvek® to current Tyvek® for sterile medical packaging. This decision marks a significant milestone in the DuPont™ Tyvek® Medical Packaging Transition Project (MPTP), a multi-year undertaking to help the medical packaging industry transition to Tyvek® manufactured using updated flash spinning equipment and technology, and signals the beginning of commercial sales of the transitioned advanced material. Health Canada also has issued their guidance on filing a modified license amendment for transition Tyvek® in Canada.
With affirmation of functional equivalence, the U.S. FDA states that it is not necessary for Medical Device Manufacturers 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. Commercial sales of transition Tyvek® can now begin in October 2015, as previously announced. Recognizing that some medical device manufacturers, especially those with Class III devices sold in Europe, are awaiting Notified Body approvals, DuPont is increasing the availability of current Tyvek® and will continue to produce this material on a schedule that is aligned with the needs of our stakeholders.
“Receiving FDA affirmation of functional equivalence and Health Canada guidance is the culmination of years of preparation, collaboration and execution of a meticulous process,” said Michael H. Scholla, Ph.D., global director, Regulatory and Standards, DuPont Protection Technologies. “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.”
Announced in 2011, the MPTP is a multi-year investment by DuPont of more than $30 million to transition Tyvek® 1073B and Tyvek® 1059B to the latest flash-spun technology and equipment to help ensure the continuity and flexibility of future supply into medical and pharmaceutical packaging applications worldwide. DuPont is working closely with Sterile Packaging Manufacturers, Medical Device Manufacturers, testing laboratories and regulatory bodies around the world throughout every phase of this project.
“We have worked successfully with DuPont for many years,” said Nick Fotis, global packaging director, Cardinal Health. “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®.”
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 are available at www.areyouready.tyvek.com. 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. DuPont will continue to post Industry Summary Reports on its website.
For more than 40 years, Tyvek® has helped to protect the health of millions of patients worldwide and to reduce costs in the healthcare setting by maintaining sterility of medical devices and supplies to the point of use. Recognized as a standard of excellence in healthcare packaging, this advanced material is used in virtually every form of sterile medical packaging, as well as a wide variety of pharmaceutical packaging applications. Along with physical barriers to infection such as sterile medical packaging, DuPont also is focused on the behavioral and biological barriers, and the company is working collaboratively to bring solutions to the global challenge of infection control.
DuPont (NYSE: DD) has been bringing world-class science and engineering to the global marketplace in the form of innovative products, materials, and services since 1802. The company believes that by collaborating with customers, governments, NGOs, and thought leaders we can help find solutions to such global challenges as providing enough healthy food for people everywhere, decreasing dependence on fossil fuels, and protecting life and the environment. For additional information about DuPont and its commitment to inclusive innovation, please visit www.dupont.com.
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