Today, the U.S. Food and Drug Administration issued final guidance document, “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” . Its recommendations seek 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 for certain sterile devices and those labeled as non-pyrogenic. Novel sterilization methods are newly developed and, therefore, have little information on their effectiveness. The Sterility Final Guidance describes measures to enhance oversight of 510(k) submissions that incorporate these sterilization methods, specifically:
- including validation protocols and data in 510(k) submissions for devices sterilized using novel methods; and
- continuation of FDA pre-clearance inspections of manufacturing facilities for sponsors that utilize novel sterilization methods.
This guidance is now final, though there will be a 60-day delayed implementation from the guidance issuance date. At that time, the recommendations in the guidance will apply to any new submissions received for device types that are within the scope of the guidance.
FDA Webinar to discuss the Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile – February 11, 2016
On Thursday February 11, 2016, the FDA will hold a webinar to help manufacturers understand the information provided in this final guidance document. Following a brief presentation, the FDA will respond to manufacturers’ questions. We welcome your questions about this final guidance, so please mark your calendars to participate. No registration is required.
Date: February 11, 2016
Time: 2:00-3:30PM, Eastern Time.
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.
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: http://www.fda.gov/CDRHWebinar. The slide presentation will be available at this site on the morning of the webinar.
Food and Drug Administration
Center for Devices and Radiological Health