FDA Posts eMDR Enhancements

FDA has posted a list of enhancements to the CDRH Electronic Medical Device Reporting (eMDR) system. An agency notice says FDA “recognizes the importance of providing early notice and predictability about potential eMDR system changes….” It says it is adopting a yearly schedule for announcing and implementing enhancements to the eMDR system. Under that schedule, FDA says, it will announce upcoming enhancements every June, release the implementation package in August, deploy enhancements to pre-production also in August, and deploy enhancements to production in March of the following year.

“While FDA expects to follow this schedule for future enhancements, it is possible that emergency fixes may need to be implemented outside the schedule,” the notice says. “Additionally, if major system changes are necessary in the future, additional time will be provided between release of the implementation package and production deployment.”