FDA Adds Vaporized Hydrogen Peroxide as Established Sterilization Method for Medical Devices

The U.S. Food and Drug Administration (FDA) has recently authorized the use of vaporized hydrogen peroxide (H₂O₂) as an established sterilization method for medical devices.

Issued in early January, the FDA’s revised Guidance document, “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile,” updates information regarding recommended sterilization methods for medical devices deemed sterile. In addition to traditional methods of sterilization, such as steam, dry heat, ethylene oxide (EO), and radiation, the updated Guidance now includes H₂O₂ as a Category A sterilization method.

Justifying its action to include H₂O₂ as a Category A sterilization method, the FDA acknowledges that “we recognize that there may be alterations to the more recently developed methods, as well as original, innovative sterilization technologies, which are being developed and proposed for use in the manufacture of class I and class II devices,”

As a reminder, Guidance documents issued by the FDA and other agencies are intended solely to provide insight into the current thinking of regulators and should be viewed only as recommendations and not requirements.

The FDA’s updated Guidance on the Submission and Review of Sterility Information in Premarket Notification Submissions for medical devices is available for download.