Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; Guidance for Industry and Food and Drug Administration Staff; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." This guidance updates and clarifies the information regarding 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.