CDRH New Update

CDRHNew

Date: October 19, 2016

The following new items were added to the CDRH web pages on October 18, 2016. Previous CDRH New Items can be found on the CDRHNew Page.

• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150033 added)
• Federal Register: Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components