CDRH New Update

CDRHNew

Date: January 21, 2016

The following new items were added to the CDRH web pages on January 20, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140025 added)
• Implanted Blood Access Devices for Hemodialysis - Guidance for Industry and Food and Drug Administration Staff
• Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff