On Jan. 8, 2024, the FDA updated the final guidance on “Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile”. Within the document, the FDA announces that it has recategorized vaporized hydrogen peroxide (VHP) to be an Established Category A sterilization process. As such, this places VHP in the same category as other traditional sterilization methods such as ethylene oxide (EtO), radiation, and steam. The change was brought about after the FDA gained sufficient confidence in the sterilization method and after the agency had recognized 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), along with two additional sterilization standards, in mid-2023. Additionally, the document provides further detailed information pertaining to pyrogenicity testing that is recommended for 510(k) submissions.
Along with the growing concerns over the use of EtO and its impact on public safety that have been raised by the Environmental Protection Agency (EPA), the FDA continues to encourage the development and use of alternative sterilization methods.
Additionally, the FDA asserts the following:
– the use of emerging “novel” sterilization technologies will continue to be scrutinized to ensure the risk of inadequate sterility assurance is mitigated with strict adherence to GMP
– that it intends to perform on-site inspections before clearing device 510(k)s using these processes.
Click here to read the guidance document.
