CDRH New Update

The following new items were added to the CDRH web pages on February 20, 2018. Previous CDRH New items can be found on the CDRH New webpage. Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff Presentation Slides added to Public Workshop - Fostering Digital Health Innovation: Developing the Software Precertification Program - January 30-31, 2018 Federal Register: Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices