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 is intended to help manufacturers understand the information provided in this final guidance document.

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

Webinar details:

Registration is not necessary.

Date: Thursday February 11, 2016
Time: 2:00PM – 3:30PM Eastern Time (please connect by 1:45PM)

To hear the presentation and ask questions:
Dial: 800-857-3797; passcode: 5390762 | International callers dial: 1-312-470-7413

To view the slide presentation during the webinar:
Conference number: PW6710051
Audience passcode: 5390762

Following the webinar, a transcript, recording and slides will be available at: The slide presentation will be available at this site on the morning of the webinar.

Note: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance for webinar attendance.

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: 11/08/2016
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