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What is the definition of "novel non-traditional sterilization methods" and are there relevant FDA guidance documents?

Last Updated On October 7, 2025

FDA recognizes three categories of sterilization methods currently used to sterilize medical devices in manufacturing settings – Established Category A, Established Category B, and Novel. These processes are defined as:

1. Established Category A: methods that have a long history of safe and effective use as demonstrated by ample literature, clearances of 510(k)s or approvals of premarket approval applications, and satisfactory QS inspections, and for which there are voluntary consensus standards for validation that are recognized by FDA.
2. Established Category B: methods that do not have a long history of safe and effective use and for which there are no FDA-recognized standards, but for which published information on validation of these methods exists and for which FDA has previously evaluated data as part of a QS evaluation and determined the methods to be adequate.
3. Novel: newly developed methods for which there are no FDA recognized standards, there is no FDA inspectional history, or there is little or no published information on validation, and for which there is no history of comprehensive FDA evaluation of sterilization validation data. A Novel Non-traditional Sterilization Method is also a method that has not been evaluated by FDA as part of a QS evaluation and that employs sterilization methods that FDA has not reviewed and determined to be adequate to provide reasonable assurance of safe and effective use.

Examples of Sterilization Methods (as of the date of this guidance):

• Established Category A: Dry Heat, Moist Heat, ETO (fixed chamber), Gamma Radiation, Vaporized Hydrogen Peroxide
• Established Category B: Hydrogen Peroxide / Gas Plasma, Ozone, Pulsed Light, Sound Waves
• Novel: Chlorine Dioxide, Ethylene Oxide – ETO-in-a-bag (Diffusion method, Injection method), Vaporized Chemical Sterilant Systems (e.g., peracetic acid), Nitrogen Dioxide