FDA’s eMDR System Enhancements for 2022

FDA Announces Schedule Enhancements for eMDR System

If your email program has trouble displaying this email, view as a webpage. FDA Announces Schedule for Enhancements to its Electronic Medical Device Reporting (eMDR) System as well as 2022 Enhancements The U.S. Food and Drug Administration (FDA) is updating its eMDR system with a planned yearly enhancement schedule. The FDA recognizes that it is important for manufacturers submitting reports via AS2 to have early notice and predictability for potential eMDR system enhancements. While the FDA expects to follow this schedule for future enhancements, it is possible that emergency fixes may need implementation outside this schedule. Additionally, if major system changes are necessary in the future, additional time will be provided between release of the implementation package and production deployment. Any changes to this schedule will be announced. The schedule for eMDR enhancements as well as the list of enhancements for 2022 can now be found on the eMDR System Enhancements webpage. Read More Questions? Please contact the eMDR helpdesk at eMDR@fda.hhs.gov  for any questions or concerns about specifications and enhancements.

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