FDA Jumps on AI Bandwagon

The FDA is going high tech.

According to Evan Sweeney, a writer for MedTech, the agency will use computer modeling (AI aka artificial intelligence) to modernize its regulatory process. The goal will be to accelerate the agency’s ability to evaluate medical product innovation. This decision represents a new approach that will use computer models and virtual patients to speed up the approval process.

In July, the FDA released a work plan detailing how it plans to meet requirements of the law—which was intended to accelerate the ability of industry to innovate medical technology, according to Sweeney. “FDA is working hard to maximize the authorities & resources Congress granted us to advance medical innovation for patients.”—said FDA Commissioner Scott Gottlieb. In a blog post, he outlined the FDA’s move toward “in silico clinical trials” that use computer simulations to evaluate new devices and drugs.

Gottlieb wrote, “Right now, FDA is collaborating with scientists to develop such natural history models in Parkinson’s disease, Huntington’s disease, Alzheimer’s disease, and muscular dystrophy. An important objective of modeling and simulation is to better evaluate the behavior of new treatments in rare disease populations that are inherently hard to study due to their small size.”