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...
A recent article gives the FDAs strategy and opinion on the standards that are currently in existence and new standards that are being developed for sterilizers, sterilization processes, and associated devices for low-temperature vaporized hydrogen peroxide (VH2O2) sterilization. VH202 is being used to sterilise reusable devices where...
Global supply chain shortages continue to have an impact on the availability of sterilisation capacity. Ethylene Oxide (EO) sterilization facility shutdowns and raw material scarcity are affecting the medical device industry. In order to alleviate these disruptions, the FDA announced a 510k Sterility Pilot Program which...