FDA Updates List of AI/ML-Enabled Medical Devices

The United States’ Food and Drug Administration (FDA) has added 171 new products to its list of artificial intelligence (AI) and machine learning (ML) enabled devices legally marketed in the US via its 510(k), De Novo or premarket approval pathways.

The list, while not exhaustive, is maintained by the FDA in its efforts to boost transparency about new AI/ML-enabled devices emerging in a fast-moving sector.

With the update also came commentary on recent related data trends, including a year-over-year growth of AI/ML-enabled devices in 2023 anticipated to exceed 30 percent.

“One of the greatest potential benefits of AI/ML resides in its ability to create new and important insights from the vast amount of data generated during the delivery of health care every day,” said the FDA in an announcement.

“Ensuring that these innovative devices are safe and effective, and that they can reach their full potential to help people, is central to the FDA’s public health mission.”

The update comes in the same month as the FDA established a new advisory committee to help the agency tackle the benefits and risks of using such technologies in healthcare settings.

The Digital Health Advisory Committee, comprised of experts with related technical and scientific backgrounds, will work to ensure AI/MI-enabled devices are designed with end-user outcomes in mind. It is set to be fully operational by 2024.

“Technology moves at an incredible pace, and we’re excited to have a committee of experts throughout the field who can help ensure our regulation of these exciting tools maintains an appropriate pace while working within parameters of safety and effectiveness standards,” said FDA Digital Health Center of Excellence Chair, Troy Tazbaz in a statement.

“Many of these technologies are novel and tend to rapidly change; it’s our duty to seek as much knowledge on them as possible as we determine and implement appropriate regulation to encourage innovation while protecting public health.”

Read the announcement from the FDA including the full list of devices, and an update regarding the establishment of its new Digital Health Advisory Committee.