EO-FCT is a non-traditional sterilization process using 100% EO. Unlike traditional EO sterilizers, which involved rigid metal chamber and large external tanks of gas, Andersen Sterilizers’ uses gas impermeable sterilization bags and unit dose 100% EO cartridges. At the start of the cycle, excess air is removed from the bag, eliminating chamber dead space. A tiny fraction of EO is then employed to sterilize. After abatement, emissions are reduced by 99%—effectively zero emissions.
According to the FDA, here’s what happens next.
Participants selected for this challenge will work directly with the FDA to accelerate the development and review of innovative technology.
Within 60 days of announcing the participants, the collaboration phase of the process will begin. The goals of the collaboration phase are to:
- Create a mutual understanding of the target technology profile including the important risks and benefits.
- Discuss the development of the technology or potential regulatory pathways going forward.
The FDA will work closely with the participants selected for the challenges. The regulatory standard of demonstrating a reasonable assurance of safety and effectiveness still applies. Review of these challenge submissions does not constitute regulatory acceptance or endorsement of a process associated with a premarket submission. These methods or technologies would still have to be reviewed through the relevant premarket pathway.