This page lists recent and upcoming enhancements to CDRH's Electronic Medical Device Reporting (eMDR) system. The eSubmitter client is updated concurrently with eMDR, but AS2 submitters should use the information on this page to plan system updates to comply with these eMDR changes as soon as possible.
For more information on the precise changes to eMDR, see the implementation package.
There are currently no upcoming changes scheduled for the eMDR system.
|Supplement Numbering Requirements Enforcement||The eMDR system was updated to enforce requirements related to supplement report numbering. In the past, supplements that were sent with incorrect follow-up numbers (for example, a supplement #2 for a report without supplement #1) would be accepted and placed into “supplement hold” while the eMDR system waited for the missing supplement(s) to arrive. Now, a supplement with an incorrect follow-up number will be rejected, and Ack3 will contain a message explaining which follow-up numbers are missing for the report in question. For more information on the new Ack3 error messages, please view the sample acknowledgement files in the eMDR Implementation Package.||Production deployment to eMDR on December 27, 2018|
|FDA Adverse Event codes update||The list of FDA Adverse Event codes accepted in F10 and H6 was updated to harmonize with the IMDRF Adverse Event Reporting Terminologies. This update affected the Device Problem Codes and Manufacturer Evaluation Codes, which correspond to IMDRF Annexes A through D. Future updates will harmonize all remaining FDA adverse event codes with IMDRF as more annexes are published. IMDRF codes are not accepted by eMDR, but the new hierarchies posted on FDA.gov include a one-to-one mapping of IMDRF codes to FDA codes. AS2 submitters who use FDA codes retired during this update will have their report rejected by eMDR. For more information on the new and retired codes, please view the hierarchy and disposition files posted at MDR Adverse Event Codes.||Test deployment to eMDR on March 6, 2018. Production deployment to eMDR and eSubmitter on July 5, 2018|
|Environment and Submission Type elements added to Ack3||A new element indicating the submission environment (production or test) was added to both the HTML and XML Ack3. This element allows submitters to detect when they have accidentally submitted to the wrong environment. Also, a new element indicating the CDRH submission type (3500A for eMDR) was added to both versions of Ack3.||Test deployment to eMDR on April 7, 2017. Production deployment to eMDR on October 2, 2017|
|HL7 ICSR R2 XML format update||The eMDR system was updated to accept HL7 ICSR R2 format XML, and eSubmitter was updated to generate R2 XML for all submissions. Although the R2 schema allows for multiple devices and multiple patients in a single report, eMDR will continue to accept only one device and one patient per report. AS2 submitters can indicate whether their XML is in R1 or R2 format using a new schema element (submissions without this element will continue to be processed as R1). After a one year grace period, eMDR ceased accepting R1 format submissions on July 5, 2018.||Production deployment to eMDR and eSubmitter on June 29, 2017|
|Combination product fields added||The new eMDR ICSR R2 XML includes elements from sections C and G of the 3500A that contain drug information. This allows submitters to include information of up to 20 drugs within a device-led combination product adverse event report in eMDR.||Production deployment to eMDR and eSubmitter on June 29, 2017|
|3500A version 9/30/2018 updates||The eMDR system was updated to include fields from the newest version of the 3500A form. The major addition was section A5 (Ethnicity/Race). This field is not mandatory for eMDR submissions, but FDA requested that AS2 submitters add this field to their systems by July 5, 2018.||Production deployment to eMDR and eSubmitter on June 29, 2017|
|D4 UDI guidance update||Submitters were previously instructed to enter the full human-readable UDI in the D4 UDI field. This guidance has been updated to request that manufacturers include only the DI portion of the UDI in this field. User Facility reporters that are not aware of the suspect medical device's DI should continue to enter the full human-readable UDI printed on the device.||Effective June 1, 2017|
|Mandatory B5 and H1||Manufacturer initial reports must include a value for B5 and H1. Reports that contain only whitespace for B5 will be rejected. Reports that do not indicate Death, Serious Injury, or Malfunction in H1 will be rejected.||Production deployment to eMDR and eSubmitter on February 2, 2017|