This announcement is being sent by the eMDR Team to provide additional information about the timing of the eMDR update on July 5, 2018. This update will affect both eSubmitter users and AS2 B2B submitters to eMDR.
The first change in this update is the addition of new FDA adverse event codes and the retirement of old codes in the Device Problem Code (DPC), Manufacturer Evaluation Method Code (EMC), Manufacturer Evaluation Result Code (ERC), and Manufacturer Evaluation Conclusion Code (ECC) sets used in F10 and H6, which was announced in November 2017. The second change in this update is the retirement of HL7 ICSR R1 XML, which was announced in June 2017.
The eMDR system will be updated during a several-hour downtime on the evening of July 5, 2018. AS2 submitters should cease sending reports containing retired codes at 5:00 p.m. Eastern Standard Time on July 5, and may commence sending reports containing new codes at 9:00 a.m. Eastern Standard Time on July 6. Submissions containing retired codes or R1 XML will be rejected by eMDR once the update is complete.
eSubmitter will automatically update for all users on July 5. Some users may receive the eSubmitter update before eMDR is updated during the evening on July 5. eSubmitter users should not submit any reports containing a new code until 9:00 a.m. Eastern Standard Time on July 6. New FDA codes are easily identified by having four digits and beginning with the numeral four (4).
The eMDR website, MDR adverse event codes website, and the eMDR implementation package have been updated on FDA.gov to synchronize with this system update.
eMDR System Enhancements page link: https://www.fda.gov/
MDR Adverse Event Codes page link: https://www.fda.gov/
eMDR Implementation Package link: https://www.fda.gov/
Thanks,
eMDR Team
eMDR Team
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