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