Quick Tip: Follow FDA action to learn about safety and effectiveness of AI/ML devices
A growing number of FDA approvals and clearances of AI/ML devices offer a unique opportunity to understand the Agency's expectations of safety and effectiveness.
Medical device innovation using artificial intelligence/machine learning (AI/ML) technologies is advancing at an accelerating pace. In response, the regulatory approach to evaluating safety and effectiveness of these devices is trying to keep up. There is a lot of uncertainty about the type and amount of clinical data is needed to answer the regulatory questions about safety and effectiveness.
We can learn a lot by studying the more than 500 AI/ML enabled devices the US FDA has approved or cleared so far. There has been a nearly exponential growth in the number of devices cleared by the FDA in the last 5 years.
It is a good idea to review publicly available information about these devices to understand the Agency’s evolving expectations. Each device is different in how it utilizes the AI/ML technology and the level of uncertainty present in the overall benefit-risk evaluation.
See the article below for a review of 5 AI/ML enabled devices recently cleared by the FDA.
