CDRH New Update

The following new items were added to the CDRH web pages on November 30, 2017. Previous CDRH New items can be found on the CDRH New webpage. Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170041 added) Added Presentation and Transcript to Webinar - PreCertification (Pre-Cert) Pilot Update - November 17, 2017  Added Presentation and Transcript to Webinar - De Novo Classification Process (Evaluation of Automatic Class III Designation) - November 21, 2017 Press Release: FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers