FDA has completed the addition of new elements and fields to its Electronic Medical Device Reporting (eMDR) system, designed to enable data entry and processing of adverse event reports for devices.
The changes, which also affect the public Manufacturer and User Facility Device Experience (MAUDE) database, include the addition of new fields for summary reports and combination products. The agency adopted the changes to bring eMDR in line with the latest version of its reporting form and to complete its harmonization with international reporting terminologies such as adverse event codes.
Separately, FDA on Wednesday updated information on adverse event reporting for devices under emergency use authorization (EUA) or COVID-19 enforcement policy guidance.
Under a 2014 final rule, manufacturers and importers are required to submit MDRs to the FDA in an electronic format that it can process, review, and archive. FDA spent the summer working to implement several sets of enhancements to eMDR that it disclosed in May. As planned, the agency completed a test deployment last month and brought the changes into effect this week.
Most aspects of the update are identical to the plans FDA set out earlier this year. That means the eMDR system now includes new options on patient gender and new fields on summary reports and combination products featured in the latest version of the FDA Form 3500A for safety reporting. Other changes include the addition of adverse event codes that complete the harmonization with the terminologies set by the International Medical Device Regulators Forum.
The changes that took effect this week include one revision that was absent from the plans FDA posted in May. That revision relates to a change in the handling of exemption numbers that will spare submitters from the need to report the information in another part of their filings.
Otherwise, the sole differences between the planned and executed actions relate to the timeline for phasing out the codes and elements replaced in the update. FDA had planned to stop accepting retired patient problem codes and device component codes in late November 2020. The agency set the same date for the cessation of the reporting of number of events (NOE) elements in the event narrative.
Having completed the changes, FDA has agreed to give the industry more time to adapt. FDA will now stop accepting the product codes and NOE elements in the event narrative at the end of February 2021. The agency set the same deadline for switching to the new way of sharing exemption numbers.
The updates are now live in the eMDR system, eSubmitter and the MAUDE database. FDA also changed MAUDE to make patient problem codes and marketing submission numbers available in the public version.
As for manufacturers who have brought products to market during the pandemic, FDA updated a frequently asked questions document on Wednesday regarding adverse event reporting for manufacturers who have devices under emergency use authorization or available under a COVID-19 enforcement policy guidance. The list in part outlines how manufacturers can sign up for an eMDR account using an FDA establishment identifier number to submit MDRs electronically.