The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) plans to update the FDA’s electronic medical device reporting (eMDR) system to reflect updates to the FDA Form 3500A and other system enhancements. The FDA Form 3500A is used by manufacturers, distributors, importers, and user facilities to report medical device adverse events. These updates will allow the public to more easily analyze events in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.
The FDA updated the FDA Form 3500A to include:
- New structured data fields to show if a report represents a summary of multiple events (for example, Voluntary Malfunction Summary Reports),
- A data field to capture the number of events being summarized, and
- New options for the data field that captures patient gender.
The updated FDA Form 3500A is available now in paper form and can be referenced by user facilities who report medical device adverse events in paper form. The electronic version of the updated FDA Form 3500A will be available for use by manufacturers, distributors, and importers later in 2020. Until that time, these mandatory reporters will use the current electronic version of the FDA Form 3500A.
The FDA will update the eMDR system to:
- Match the changes to the data fields in the updated FDA Form 3500A,
- Include adverse event codes to harmonize with International Medical Device Regulators Forum (IMDRF) terminologies, and
- Enable a reporter to identify whether the report relates to a combination product.
The eSubmitter client is updated concurrently with eMDR, but AS2 submitters should plan system updates to align with these eMDR changes as soon as possible.
The FDA will continue to provide updates as we work to ensure a smooth transition with the use of this new form electronically.