This communication serves as a follow-up to a previous email notice, sent on June 8, 2017, regarding the Electronic Medical Device Reporting (eMDR) program’s system updates. In this communication, the FDA notified industry of pending eMDR system enhancements. As of June 26, 2017, these updates are now available for public access, download, and review on the FDA website. The specific changes being implemented are outlined in the new table on the eMDR System Enhancements webpage (linked below). The Health Level 7 (HL7) Individual Case Safety Reporting (ICSR) Files have also been updated. If your firm utilizes the HL7 submission method, please review these files thoroughly.
If you have additional questions or concerns regarding these changes, please contact the eMDR Helpdesk ateMDR@fda.hhs.gov.