CDRHNew - News and Updates

CDRHNew - News and Updates

The following new items were added to the CDRH web pages on December 7, 2017. Previous CDRH New items can be found on the CDRH New webpage. Software as a Medical Device (SAMD): Clinical Evaluation - Guidance for Industry and Food and Drug Administration Staff Clinical and Patient Decision Support Software - Draft Guidance for Industry and Food and Drug Administration Staff Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act - Draft Guidance for Industry and Food and Drug Administration Staff Public Workshop - Fostering Digital Health Innovation: Developing the Software Precertification Program - January 30-31, 2018 Software as a Medical Device (SaMD) Federal Register: Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act Federal Register: Clinical and Patient Decision Support Software Federal Register: Software as a Medical Device - Clinical Evaluation Federal Register: Fostering Digital Health Innovation: Developing the Software Precertification Program; Public Workshop