In addition to food and drugs, the FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential, well-performing tools of modern healthcare, but occasionally they present a safety issue due to risks not identified in prior studies, a malfunction, a problem with manufacturing, or misuse.

These incidents are collected in a publicly available FDA database called MAUDE—short for Manufacturer and User Facility Device Experience. As part of the openFDA project, there is now an application programming interface (API) for this dataset, which provides a way for software to interact directly with the data. This API will allow developers and researchers to easily query thousands of reports dating back to the early 1990s.

The API can be a powerful tool for generating hypotheses for further investigation or inquiry, and can inform the development of safer, more effective technologies. For example, it can help identify new, potential safety signals as well as which classes of devices may be associated with particular adverse events.

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