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Guidance on Submitting Sterility Info in 510(k)s for Sterile Devices


Federal Register Notice: FDA is making available a guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. It updates and clarifies the information on sterilization processes that FDA recommends sponsors include in 510(k)s for devices labeled as sterile. This guidance document also provides details about the pyrogenicity information that FDA recommends sponsors include in a 510(k) submission. To download this guidance, click here. To view this notice, click here.