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  • Writer's pictureKBM

FDA Recognizes Vaporized Hydrogen Peroxide for Sterilization.

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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