CDRH New Update

CDRHNew

Date: February 3, 2016

The following new items were added to the CDRH web pages on February 2, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff
• Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices - Draft Guidance for Industry and Food and Drug Administration Staff
• List of Highest Priority Devices for Human Factors Review - Draft Guidance for Industry and Food and Drug Administration Staff
• PMA Final Decisions for December 2015