FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization
LifeProNow
JANUARY 19, 2024
The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization. EtO is the most commonly used sterilization method for medical devices in the U.S.,
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