Michael S. Heyl
Partner
Washington, D.C.
DuPont's Upgraded Manufacturing Process Regarding Their Tyvek® Material and Impact on Medical Device Manufacturers
05 October 2015
Medical Device AlertIn an announcement issued by the Food and Drug Administration on October 2, 2015, the agency has determined that the performance of the new Tyvek® material is functionally equivalent to existing 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.
Contacts
Randy J. Prebula
Partner
Washington, D.C.
Edward C. Wilson, Jr.
Partner
Washington, D.C.
Leif E. Olsen
Director of Regulatory Sciences
Washington, D.C.
W. Alex Smith
Director of Regulatory Sciences
Washington, D.C.
