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