FDA Issues Draft Guidance For AI-Enabled Medical Devices

The U.S. Food and Drug Administration (FDA) released draft guidance on January 6, 2025, to support the development and marketing of AI-enabled medical devices throughout their Total Product Life Cycle.

In their news release, the FDA explains that if finalized, this guidance would be the first to provide comprehensive recommendations covering design, development, maintenance, and documentation, aimed at ensuring the safety and effectiveness of these devices. The guidance is set to be published in the Federal Register on January 7, as reported by Healthcare IT News (HITN).

This draft guidance complements recently issued recommendations on predetermined change control plans for AI-enabled devices, outlining how developers can proactively plan for product updates aftermarket release.

Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence, emphasized the significance of this guidance in addressing the unique considerations of AI-enabled devices.

“The FDA has authorized more than 1,000 AI-enabled devices through established premarket pathways. As we continue to see exciting developments in this field, it’s important to recognize that there are specific considerations unique to AI-enabled devices,” he stated, as reported on the FDA press release.

Key components of the draft guidance include recommendations on how sponsors should describe the postmarket performance and risk management of AI-enabled devices in marketing submissions. It highlights the importance of early and ongoing engagement with the FDA and offers a comprehensive approach to managing risks throughout a device’s lifecycle.

Additionally, the draft addresses strategies to mitigate transparency and bias concerns, providing detailed recommendations to help sponsors identify and manage risks associated with bias during design and evaluation.

The FDA also released draft guidance on using AI in developing drug and biological products, further reflecting the agency’s commitment to fostering innovation while maintaining safety and transparency.

This announcement comes amid the rapid growth of AI, which is transforming healthcare by enhancing diagnostics, predictive analytics, psychological treatment plans, and even medical education.

However, HITN notes in a blog post co-authored by Tazbaz and John Nicol, FDA experts highlighted the significant risks posed by AI’s adaptability in real-world settings, including exacerbating biases in data and algorithms, potentially harming patients and disadvantaging underrepresented populations.

To address these evolving risks, the FDA introduced principles for life cycle management and proposed guidance ensuring performance considerations—such as race, ethnicity, and gender—are prioritized throughout AI/ML device development and monitoring, as reported on HITN.

Public comments on the draft guidance are open until April 7, 2025. The FDA specifically seeks feedback on its alignment with the AI lifecycle, recommendations for addressing emerging technologies like generative AI, and performance monitoring approaches.

Finally, the FDA also stated that a webinar is scheduled for February 18, 2025, to discuss these proposals further.