CDRH New Update

CDRHNew

Date: September 29, 2016

The following new items were added to the CDRH web pages on September 28, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• 24 Hour Summary posted for September 20-21, 2016 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting
• Class I Medical Device Recall: DePuy Synthes Recalls Power Tool System Battery Adaptors Due to Possible Explosion Risk
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN110011 and DEN150056 added)
• Information on the Artificial Pancreas Device System
• Presentation and Transcript added to Webinar - Final Guidance on Adaptive Designs for Medical Device Clinical Studies - September 22, 2016
• Presentations posted for September 20-21, 2016 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee meeting
• Consumer Information on: The 670G System - P160017
• Updated the Expedited Access Pathway Program website with two Data Development Plan Examples