Source: STAT News

STAT News reports that the U.S. Food and Drug Administration (FDA) has decided to reduce its direct oversight of certain AI-enabled medical devices and wearables. The new policy focuses on tools considered "low-risk," such as wellness trackers and apps that provide lifestyle recommendations. This decision is part of a broader strategy to encourage innovation by allowing tech companies to bring software updates and new features to market more quickly without waiting for lengthy federal approval processes.

However, the policy change has sparked concerns among health advocates who worry about the accuracy and reliability of unregulated medical algorithms. The FDA argues that its resources are better spent on high-risk, life-sustaining medical technologies, while low-risk devices will be subject to less frequent pre-market review. From a legal perspective, this shift may lead to a rise in product liability litigation, as consumers will no longer be able to rely on the "FDA Approved" status as a guarantee of efficacy. The agency plans to replace strict pre-market oversight with enhanced post-market monitoring to detect potential safety issues once products are already in use by the public.