Date: December 8, 2015
The following new items were added to the CDRH web pages on December 7, 2015. Previous CDRH New Items can be found on theCDRHNew Page.
- Evaluation of Automatic Class III Designation (De Novo) Summaries added
- Class I Medical Device Recall: eVent Medical LS, 5i, or 7i Inspiration Ventilators May Shut Down without Alarm
- Federal Register: Moving Forward: Collaborative Approaches to Medical Device Cybersecurity; Public Workshop; Request for Comments