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CDRH Industry: Update to Final Guidance Document: “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile”

On March 16, 2016, the FDA posted an updated version of the Sterility Final Guidance, originally published as final on January 21, 2016. The guidance was updated to correct an inadvertent editorial change from the draft guidance that might be interpreted as a recommendation to submit data on endotoxin levels per device as unit/device rather than the expression of the endotoxin limit as unit/device.

The updated guidance information on recommendations for information submitted on endotoxin limits is outlined below:

  • A description of the method used to make the determination that the device meets pyrogen limit specifications (e.g., bacterial endotoxins test (BET), also known as the Limulus amebocyte lysate (LAL) test);
  • A statement confirming that endotoxin testing will be conducted on every batch or if not, information regarding the sampling plan used for inprocess testing and/or finished product release, as recommended in the FDA guidance, Pyrogen and Endotoxins Testing: Questions and Answers
  • Identification of the chosen testing limit
  • An explanation supporting the selected endotoxin limit.

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at, 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health