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Use A Novel Sterilization Method, Expect A Pre-510(k) Inspection, FDA Says

This article was originally published in The Gray Sheet

Executive Summary

A guidance document on requirements for sterile devices sets three categories for sterilization methods and asks submitters to supply the most detailed information for newly developed sterilization techniques that have not been fully evaluated by FDA. The agency also says it will not clear a 510(k) relying on a novel sterilization method without first conducting a facility inspection.