Hogan Lovells Publications | Medical Device Alert | 05 October 2015
DuPont's Upgraded Manufacturing Process Regarding Their Tyvek® Material and Impact on Medical Device Manufacturers
In 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.
Download PDF Back To Listing
Contacts
Partner
Washington, D.C.
Partner
Washington, D.C.
Partner
Washington, D.C.
Director of Regulatory Sciences
Washington, D.C.
