CDRH New Update

CDRHNew

Date: December 23, 2016

The following new items were added to the CDRH web pages on December 22, 2016. Previous CDRH New Items can be found on the CDRHNew Page.

• CDRH Fiscal Year 2017 (FY 2017) Proposed Guidance Development and Focused Retrospective Review of Final Guidance
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150022, DEN150038, DEN150057 added)
• FDA Warns Health Care Providers Against Relying Solely on Zika Virus Serological IgM Assay Results; Reminds them to Wait for Confirmatory Test Results Before Making Patient Management Decisions: FDA Safety Communication