Sterility Information in Premarket Notification (510(k))

The FDA has issued the Sterility final guidance for submissions of  Devices Labeled as Sterile. The scope of this guidance is limited to the review of 510(k)s for devices labeled as sterile that are subject to industrial terminal sterilization processes based on microbial inactivation.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm109897.pdf