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# Guide on Sterility Info in 510(k) Submissions
- URL: https://www.fdaweb.com/guide-on-sterility-info-in-510-k-submissions/
- Published: 2024-01-10T12:00:00.000Z
- Updated: 2026-09-14T14:20:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156113

FDA has revised its [guidance](https://www.fda.gov/media/74445/download?ref=fdaweb.com) entitled “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” to update the lists of established sterilization methods. It also provides details about the pyrogenicity information that is recommended for sponsors to include in a 510(k) submission. The document supersedes the guidance recommendations in the same titled document dated 3/16/2016.