The FDA has now finalized the 2024 guidance for 510(k) information required for sterilization of reusable medical devices with some exclusions. (See https://www.fda.gov/media/74445/download?attachment). Now included in the Category A method of sterilization is Vaporized Hydrogen Peroxide. Manufacturer instructions for use must be validated to utilize this system. Please see https://array.aami.org/content/news/fda-embraces-vaporized-hydrogen-peroxide-medical-device-sterilization.
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