CDRH New Update

The following new items were added to the CDRH web pages on November 15, 2017. Previous CDRH New items can be found on the CDRH New webpage.

• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170018 and DEN170058 added)
• CDRH’s Approach to Tumor Profiling Next Generation Sequencing Tests
• Press Release: FDA unveils a streamlined path for the authorization of tumor profiling tests alongside its latest product action
• Press Release: FDA grants marketing authorization of the first device for use in helping to reduce the symptoms of opioid withdrawal