CDRH New Update

The following new items were added to the CDRH web pages on October 31, 2018. Previous CDRH New items can be found on the CDRH New webpage . 

• Press Release: FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism 
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180028 added)