CDRH New Update

The following new items were added to the CDRH web pages on April 11, 2018. Previous CDRH Newitems can be found on the CDRH New webpage. Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria - Draft Guidance for Industry and Food and Drug Administration Press Release: FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems Federal Register: Expansion of the Abbreviated 510(k) Program; Demonstrating Substantial Equivalence Through Performance Criteria