The Food and Drug Administration (FDA) is the United States’ regulatory agency that oversees the production of human and veterinary drugs, biological products, food supply, cosmetics, products that emit radiation and finally medical devices. They protect public health by ensuring the safety of our nation’s food supply, cosmetics, and medical products. As the FDA oversees the production of medical devices, one of the biggest questions artificial intelligence (AI) developers trying to enter the US market asks is how the FDA considers regulation of AI medical devices.
Traditionally, the FDA reviews medical devices through a pre-market pathway, such as 510(k), De Novo classification, or premarket approval. However, AI enabled medical devices are a new breed for the FDA leading to review how clear modifications to medical devices, including software as a medical device (SaMD), depending on the usage and risk posed to patients of that modification can be made. On April 2, 2019, the FDA published a discussion paper “US FDA Artificial Intelligence and Machine Learning Discussion Paper” that describes the FDA’s foundation for a potential approach to premarket review for artificial intelligence and machine learning-driven software modifications, which was later ratified as an Action Plan.
If becoming an FDA regulated AI-enabled medical device is your company’s plan, here are some terms you should be familiar with:
510(k)
A 510(k) is a set of rules your company needs to follow about your device and its performance and safety. You need to submit that to the FDA for clearance before you can sell your device in the US. In order to receive clearance from the FDA, your 510(k) will need to demonstrate that your medical device is equivalent to another already marketed device (a predicate device). The substantial equivalence approval process is a simple equation that looks something like this: