FDA Issues Final Guidance on Sterilization of Medical Devices

The FDA has issued a final guidance on the sterilization of devices labeled as sterile. The guidance updates and clarifies the information regarding sterilization processes that the FDA recommends sponsors include in 510(k)s for devices labeled as sterile. Additionally, the FDA now considers Vaporized Hydrogen Peroxide (VHP) as an Established Category A sterilization process.

Revised Recommendations

The updated guidance provides the industry with revised recommendations on the information to provide in future 510(k) submissions for devices labeled as sterile including those that use VHP as their sterilization method. 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). 

See the final guidance document here.

The FDA will also be holding a series of town halls to further discuss medical device sterilization. The next town hall will be on March 21, 2024.

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