AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products.

• The first article—“Is the Eye the Window to Alzheimer’s?”—discusses several approaches that companies are exploring for use of AI in the diagnosis of Alzheimer’s Disease, including AI-enabled software for retinal scans and identification of genetic triggers.
• In the second article—“Why AI is Medicine’s Biggest Moment Since Antibiotics”—Dr. Lloyd Minor, Dean of the Stanford University School of Medicine discusses both the potential promise of increasing use of AI in healthcare settings (e.g., increased access to care in rural areas) and its potential risks (e.g., demographic bias of data fed to algorithms).
• The third article—“Your Medical Devices are Getting Smarter. Can the FDA Keep them Safe”—focuses on FDA’s role in regulating clinical applications of AI/ML technologies and the impact of FDA’s regulatory requirements on the type of products developers choose to bring to market and how quickly they can be improved once there. In particular, the article discusses FDA’s April 2023 draft guidance on pre-determined change control plans (which we previously blogged on here) and whether such plans afford sufficient flexibility for AI/ML developers to innovate and improve products based on new data while also providing sufficient guardrails to ensure patient safety.

Meanwhile, FDA’s AI/ML-focused initiatives continue to expand.  On October 11, 2023 FDA announced the establishment of a new Advisory Committee on Digital Health Technologies that is tasked with, among other responsibilities, helping the Agency navigate complex scientific and technical issues related to AI/ML-enabled devices. Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year. Among these are plans to finalize FDA’s guidance on predetermined change control plans for AI/ML-enabled devices and a draft guidance on lifecycle management considerations and premarket submission recommendations for such devices.

With more than 500 devices currently on FDA’s list of cleared AI/ML-enabled devices, these initiatives signal FDA’s recognition that these devices will continue to play a significant and increasing role in the delivery of healthcare in the years to come. We will continue to monitor ongoing developments in this field and are available to assist product developers with their development and regulatory strategies.