CDRH New Update

CDRHNew

Date: February 4, 2016

The following new items were added to the CDRH web pages on February 3, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Applying Human Factors and Usability Engineering to Medical Devices - February 19, 2016
• Federal Register: Applying Human Factors and Usability Engineering to Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
• Color Additives for Medical Devices - February 12, 2016
• Federal Register: Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150005, DEN150008, DEN150013 added)
• Federal Register: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
• Federal Register: List of Highest Priority Devices for Human Factors Review; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
• Mammography Facilities: Understanding Your Role in Medical Device Reporting
• Patient and Consumer Stakeholder Meeting Minutes, January 11, 2016