Artificial intelligence in the management of inflammatory bowel disease: What’s next?

Figure 3 Food and Drug Administration roadmap for approval of artificial intelligence as software as a medical device: There are four major areas of software development for software as a medical device. Figure created with BioRender.com (https://BioRender.com/t8xxcz4). In pre-development, the architecture and infrastructure behind the model is discussed, and involves key stake holders such as the Food and Drug Administration. In development, focus shifts towards model validation while ensuring usability of the software and refining the user interface. During approval and deployment, models may be submitted to the Food and Drug Administration through different regulatory pathways such as 501 (k). During this time, a predetermined change control plan may be submitted, which allows for premarket approval of future modifications to a device. In post-marketing, feedback is gained on the model in the real-world setting with periodic model refinements per predetermined change control plan. FDA: Food and Drug Administration; PCCP: Predetermined change control plan.