An FDA Guide on Indications for Use and Device Reporting of Artificial Intelligence-Enabled Devices: Significance for Pediatric Use

Radiology has been a pioneer in adopting artificial intelligence (AI)-enabled devices into the clinic. However, initial clinical experience has identified concerns of inconsistent device performance across different patient populations. Medical devices, including those utilizing AI, are cleared by the US Food and Drug Administration (FDA) for their specific indications for use (IFU). IFU describes the disease or condition the device will diagnose or treat, including a description of the intended patient population. Performance data evaluated during the premarket submission support the IFU and includes the intended patient population. Understanding the indications for use of a given device is thus critical to ensuring that the device is used properly and performs as expected. When devices do not perform as expected or malfunction, medical device reporting is an important way to provide feedback about the device to the manufacturer, the FDA, and other users. This paper describes the ways to retrieve the IFU and performance data information as well as the FDA medical device reporting systems for unexpected performance discrepancy. It is crucial that imaging professionals, including radiologists, know how to access and utilize these tools to improve the informed use of medical devices for patients of all ages.