CDRH New March 13, 2019

The following new items were added to the CDRH web pages on March 12, 2019. Previous CDRH Newitems can be found on the CDRH New webpage. Medical Device Development Tools (MDDT) - New Qualified Tool: OSIRIX CDE Software Module Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180021 added) FDA In Brief: FDA takes new step to help advance the development of novel treatments for traumatic brain injury with the qualification of a medical device development tool