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FDA Updates Final Guidance on Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile

Today, the U.S. Food and Drug Administration (FDA) updated the final guidance: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. The FDA now considers vaporized hydrogen peroxide (VHP) as an Established Category A sterilization process. The updated guidance provides industry with revised recommendations on the information to provide in future 510(k) submissions that use VHP.

This follows the FDA’s recognition of the International Organization for Standardization (ISO) standard ISO 22441:2022 - Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.

Moving VHP from Established Category B to Established Category A reduces the regulatory burden on manufacturers using this sterilization process for devices that need a 510(k).

Questions?

If you have questions about this final guidance, contact the Division of Industry and Consumer Education.