CDRH New Update

CDRHNew

Date: January 19, 2017

The following new items were added to the CDRH web pages on January 18, 2017. Previous CDRH New Items can be found on the CDRHNew Page.

• Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities - Questions and Answers
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140022, DEN160005, DEN150056 added)
• Medical Product Communications that are Consistent with the FDA-required Labeling - Questions and Answers