FDA – 510k Sterility Pilot Program

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 would allow current 510k holders to switch from Ethylene Oxide to a different sterilization modality without going through the 510k submission process again. Alternative sterilization methods, like supercritical carbon dioxide (scCO2) and Vaporized Hydrogen Peroxide VH₂O_2, are increasingly being recognized as safe and effective alternatives to traditional techniques.

Further information is available in a recent edition of the U.S. Federal Register. Click on the link for more information.