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# Medical Device Sterility Guidance Out
- URL: https://www.fdaweb.com/medical-device-sterility-guidance-out/
- Published: 2016-01-20T12:00:00.000Z
- Updated: 2026-09-15T02:29:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134483

> FDA has published a guidance, *Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile*, to update and clarify the information regarding sterilization processes that FDA recommends that sponsors include in 510(k)s for devices labeled as sterile. The document [says](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm109897.pdf?ref=fdaweb.com) it also provides details about the pyrogenicity information that the agency recommends sponsors include in a 510(k) submission.  
>  
> FDA says that in recent years it has received an increasing number of 510(k)s for devices labeled as sterile that use sterilization methods other than the traditional methods of steam, dry heat, ethylene oxide, and radiation. “FDA has experience with other methods, such as hydrogen peroxide, ozone, and flexible bag systems, and now considers them to be established methods,” the guidance says. “However, 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 1 and 2 devices. FDA considers these to be novel methods.”