Changes to the FDA's Electronic Medical Device Reporting (eMDR) and Manufacturer and User Facility Device Experience (MAUDE) Systems

The U.S. Food and Drug Administration (FDA) updated its systems for medical device reporting of adverse events to enhance usability of the Electronic Medical Device Reporting (eMDR) templates and to improve transparency and analysis of the medical device report (MDR) data contained in the public Manufacturer and User Facility Device Experience (MAUDE) database.

Updates to eMDR previously announced in May 2020, as described on the eMDR System Enhancements web page, are complete—including the addition of fields for summary report, number of events, and combination product—and are now available in the eMDR system, eSubmitter, and the MAUDE database.

The FDA has updated the eMDR system, eSubmitter, and the MAUDE database to add a field to help identify the exemption number, where applicable, for the medical device report (MDR). The exemption number may apply to those reports submitted under approved exemptions, variances, or alternative forms of reporting, as described in 21 CFR 803.19. No exemptions change the manufacturer's responsibility to investigate based on available information and to report MDR-reportable events.

With these new fields, the FDA expects submitters to cease reporting exemption numbers in section H10, and instead use this new Exemption Number field, along with the previously announced summary report and number of events fields, on or before February 28, 2021. The new individual field for exemption number helps identify reports associated with approved exemptions, which could previously only be found by searching for text in the narrative field.

The eMDR updates include other minor modifications to the previously announced changes, most notably involving a change to the location of the Combination Product flag. The eMDR Implementation Package file has been updated accordingly.

To align with updates approved by the International Medical Device Regulators Forum (IMDRF) earlier this year, the FDA also updated the list of Device Component codes that eMDR will accept. In addition, the FDA has extended the deadline for use of IMDRF codes in place of retired Patient Problem Codes and Device Component Codes to February 28, 2021.

In addition, the following fields from FDA Form 3500A are now available in public MAUDE:

Patient problem codes
Marketing submission number (for submissions such as 510(k) and PMA)

These fields have been added to the public MAUDE database to provide additional information on the nature of adverse events and related devices, when available.