First FDA 510(k) Clearance for a Medical Device Sterilized Using Nitrogen Dioxide

Authored by Sopheak Srun, MPH, SM(NRCM), QTS Principal Sterilization Specialist

Noxilizer, one of QTS’ partners in the medical device industry, has recently announced the first FDA 510(k) clearance of a medical device sterilized by a nitrogen dioxide (NO2) process. Nitrogen dioxide sterilization is relatively new to the medical device industry and provides an alternative sterilization method that can be used for a growing number of drugs, biologics, and medical devices that might be incompatible with ethylene oxide, gamma radiation, and other conventional sterilization methods.

FDA 510(k) clearance of a medical device sterilized by nitrogen dioxide signifies a major milestone for nitrogen dioxide sterilization processes. In the FDA’s latest guidance for 510(k) submissions, the FDA categorizes sterilization processes as either “established” (which includes conventional sterilization methods such as ethylene oxide, gamma radiation, electron beam, steam, and dry heat), or “novel” (which includes technologies without an established history for sterilizing medical devices, such as nitrogen dioxide). While the FDA typically does not require including validation protocols or validation data in 510(k) submissions for medical devices sterilized by established methods, the FDA does request that sponsors submit validation protocols and validation data for medical devices sterilized by novel sterilization methods. As such, sponsors can expect to see additional scrutiny of 510(k) submissions for medical devices sterilized by novel sterilization methods.

With this 510(k) clearance, a pathway has been established for future 510(k) submissions for nitrogen dioxide sterilized medical devices.

Among our product offerings, QTS helps many of our customers with sterilization validations and coordination of routine sterilization services. If you have questions about medical device outsourcing, please contact your QTS account manager, or email us at expert@qtspackage.com.