News & Events News

News August 2, 2022

AAMI are holding a 3.5 days advanced course is designed for professionals experienced in working with an ethylene oxide (EO) sterilization but who are now challenged with ensuring effectiveness and assessing change for the product or process. The event will be virtual and held between 29 August and...

News July 20, 2022

On June 7, 2022, the FDA announced it was considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized using radiation, including gamma radiation. The FDA is considering this pilot program due to global supply chain constraints and to...