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FDA Finalizes EtO Sterilization Guidance - Life Sciences, Biotechnology & Nanotechnology

Navigating Sterility: FDA s Comprehensive Guidelines on 510(k) Submissions for Sterile Devices

FDA's latest guidance on 510(k) submissions for sterile devices outlines priorities and updates for traditional and novel sterilization methods, ensuring a comprehensive approach to information inclusion.

FDA Recognizes Vaporized Hydrogen Peroxide (VHP) as Established Sterilization Method for Medical Devices

FDA designates vaporized hydrogen peroxide (VHP) as an Established Category A sterilization method, reducing reliance on Ethylene Oxide. Boosting innovation for safer, effective medical device sterilization.

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