Medical Devices

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Final Guidance - February 11, 2016


On January 20th, the FDA issued the Sterility final guidance, which seeks to ensure that manufacturers incorporate adequate sterilization methods for 510(k) devices labeled as sterile and provide appropriate documentation and information to the FDA for premarket review for established and novel sterilization processes. This final guidance also provides additional details about the pyrogenicity testing information that sponsors should include in a 510(k) submission.

The webinar was intended to help manufacturers understand the information provided in this final guidance document.

Following a brief presentation, the FDA responded to manufacturers' questions regarding the guidance document.

Target Audience: Industry

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

Page Last Updated: 09/12/2018
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