Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices | FDA

Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices | FDA

Updates to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) Database

The U.S. Food and Drug Administration (FDA) updated its public Manufacturer and User Facility Device Experience (MAUDE) database to improve transparency and analysis of medical device report (MDR) data.

The FDA updated the MAUDE database to add details on the individual events included in summary reports for registry exemptions in comma-separated values (CSV) format.

This update allows for analysis of the complete raw data and—along with the addition of the exemption number field in early September—aims to make more information available, including making more MDR data more easily accessible, findable, and usable to allow the public to more easily analyze events in the MAUDE database.

These exemptions do not change a manufacturer’s responsibility to investigate each event, evaluate the cause of the event, or submit individual reports when required.

Read More

Questions?

If you have questions, contact the Division of Industry and Consumer Education (DICE).