CDRH New Update

The following new items were added to the CDRH web pages on November 2, 2018. Previous CDRH New items can be found on the CDRH New webpage . 

• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170056 and DEN170092 added)
• Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking - Immediately in Effect Guidance for Industry and Food and Drug Administration Staff
• Press Release: FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery