Tyvek Is Tyvek, FDA Affirms In Letter To DuPont
This article was originally published in The Gray Sheet
Executive Summary
The industrial giant DuPont has gained validation from FDA that the vast array of medical device companies employing its Tyvek material for sterile barrier systems will not need to submit new 510(k)s or supplements when they transition to versions manufactured with new flash-spinning technology. Newly manufactured Tyvek remains "functionally equivalent" to legacy versions, the agency said.