HOME ABOUT US PRINT PUBLICATIONS SUBSCRIPTIONS CONTACT US RSS
 
Welcome to FDAweb
Pay Per View
Search our 70,569 - story database FREE
 
Free Items
 Warning Letters
 FDA Notices
 FDA Calendar
 

 FDA Whistleblowers



    








 
     
 
Guidance on Submitting Sterility Info in 510(k)s for Sterile Devices
01/21/2016
 

Federal Register Notice: FDA is making available a guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. It updates and clarifies the information on sterilization processes that FDA recommends sponsors include in 510(k)s for devices labeled as sterile. This guidance document also provides details about the pyrogenicity information that FDA recommends sponsors include in a 510(k) submission. To download this guidance, click here. To view this notice, click here.

 
 
 
Any copying or electronic transfer without written permission is strictly prohibited and will result
in termination of service and prosecution under the federal Copyright Act.
To gain permission to copy this article log on to http://www.copyright.com.

FERDIC INCORPORATED - P.O. Box 28, Camp Hill, PA 17001 | Phone: (717)731-1426 fax:(717)731-1427 Email: info@fdaweb.com