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 align with these eMDR changes as soon as possible.
For more information on the precise changes to eMDR, see the implementation package.
|Overview of Updates to the FDA Form 3500A with expiration date 2021-Nov-30||The eMDR system will be updated to include fields from the newest version of the FDA Form 3500A. The additions include new options in A3 Patient Gender, new fields for C6 Generic and Biosimilar, a new field for D8 Device Serviced By a Third Party, new options for E3 Reporter Occupation, a new field for G4 PreANDA, a new field for G5 Combination Product, new fields in H1 for Summary Report, for example, Voluntary Malfunction Summary Reports (VMSR) and Number of Events (see NOE update below), and new fields for H6 Health Effect Impact Code and Medical Device Component Code (see International Medical Device Regulators Forum (IMDRF) Annex E, F, G codes updates below). In preparation for these updates to the eMDR system, the FDA expects AS2 submitters to make the corresponding updates to their systems to provide higher-quality information about adverse events. Refer to the eMDR Implementation Package for a complete list of changes.||Test deployment to eMDR on August 14, 2020. Production deployment to eMDR and eSubmitter on September 7, 2020.|
|IMDRF Annex E, F, G Codes Updates||
The Adverse Event codes accepted in F10 and H6 will be updated to complete harmonization with the IMDRF Adverse Event Reporting Terminologies. This update will add new code sets for Annexes E (Patient Problem Code, now called Health Effect Clinical Code), F (Health Effect Impact Code), and G (Medical Device Component Code), as well as maintenance updates (including new codes) for the Medical Device Problem Code set (Annex A). A new field for component codes will be created as part of the FDA Form 3500A with expiration date 2021-Nov-30 and will no longer be accepted in other code fields. All FDA code sets have been renamed to their IMDRF names, and IMDRF codes will be accepted by eMDR in addition to the corresponding FDA and National Cancer Institute Thesaurus (NCIt) codes. For more information on the new and retired codes, please view the hierarchy and disposition files posted at MDR Adverse Event Codes.
eMDR will cease accepting retired Patient Problem Codes and Device Component Codes on November 28, 2020.
|Test deployment to eMDR on August 14, 2020. Production deployment to eMDR and eSubmitter on September 7, 2020.|
|Country Code Formats Clarification||The eMDR implementation package was updated to clarify the formatting of country codes in the address fields. Two-letter codes are interpreted as FIPS 10-4 and three-letter codes are interpreted as GENC. AS2 submitters should not send ISO 3166-1 two-letter and three-letter country codes to eMDR. Refer to the eMDR Implementation Package for a complete list of accepted country codes.||Effective May 28, 2020.|
|Summary Report and NOE Fields Added||As part of the update to the FDA Form 3500A with expiration date 2021-Nov-30, new elements for Summary Report and NOE (Number of Events) for use in summary MDR reporting will be added to H1, so that submitters will not need to report this information in B5 (Event Narrative) with precise text formatting. These elements should be used for all summary MDR reporting, for example, VMSR. The FDA expects submitters to cease reporting NOE elements in B5 on or before November 28, 2020.||Test deployment to eMDR on August 14, 2020. Production deployment to eMDR and eSubmitter on September 7, 2020.|
|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 (FDA Form 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 FDA Form 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.|
|FDA Form 3500A version 9/30/2018 updates||The eMDR system was updated to include fields from the newest version of the FDA Form 3500A. 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.|