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

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

A series of town halls will support the medical device industry by sharing the current sterilization landscape, including alternatives to ethylene oxide.

Source: mondaq.com
Navigating Sterility: FDA's Comprehensive Guidelines on 510(k) Submissions for Sterile Devices - Vimarsana News

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 - Vimarsana News

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.

FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization - Vimarsana News

FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization

Today, the FDA is announcing that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices, recognizing VHP’s long history of safety and effectiveness.

Source: fda.gov
5 Major Drug and Medical Device Developments in 2023 | Faegre Drinker Biddle & Reath LLP - Vimarsana News

5 Major Drug and Medical Device Developments in 2023 | Faegre Drinker Biddle & Reath LLP

A popular New Year’s trend is to say “goodbye” to all the things that didn’t serve you in 2023, as you usher in new intentions and habits for 2024. Although there were many great trial...