The FDA recently announced that the eMDR adverse event code update that was originally set to take place on April 6 has been rescheduled for July 5.
The delay in update will give AS2 submitters more time to develop and validate changes to adverse event compliant handling system with the test eMDR system that was updated on March 6.
AS2 submitters can also expect the eSubmitter update to occur on July 5, meaning users can continue to submit on the old adverse event code hierarchies for Device Problem Code, Manufacturer Evaluation Method Code, Manufacturer Evaluation Result Code and Manufacturer Evaluation Conclusion Code in F10 and H6 until that time.
eMDR systems will no longer accept ICSR R1 XML submissions after July 5. The last eSubmitter update occurred June 29 last year to allow the use of ICSR R2 XML. The FDA gave a one-year grace period to AS2 submitters to allow them to submit R1 XML.
The FDA has updated the website to include information on eMDR implementation package to include technical specifications for AS2 system developers. The information update on the website is designed to correct minor errors and give clarification for instructions based on frequently asked questions to the eMDR help desk.