The FDA will discuss a new framework for regulating generative artificial intelligence (GenAI)-enabled devices during a Digital Health Advisory Committee meeting this week.
The advisory committee is meeting Nov. 20-21 to address the balance between encouraging innovation and ensuring safety for this emerging technology that is reshaping the medical device industry.
According to the FDA, GenAI technologies are increasingly integrated into healthcare, offering opportunities while posing unique regulatory challenges. The FDA's executive summary for the advisory committee meeting outlines a Total Product Lifecycle (TPLC) approach to oversight, including premarket evaluation, risk management and postmarket monitoring.
Generative AI is a type of artificial intelligence that creates new data by mimicking patterns learned from training datasets. Unlike traditional AI models designed for prediction or classification, GenAI generates text, images, audio, or other outputs that resemble the data it was trained on.
Commonly built on "foundation models," these systems are versatile but lack the transparency of traditional AI, complicating their use in medical applications, the FDA says.
For medical devices, GenAI could streamline clinical workflows, improve diagnostic accuracy, and assist in medical training. For example, GenAI-enabled devices might analyze complex medical images or generate synthetic data for research and simulation purposes. However, the adaptability of GenAI models introduces risks such as producing "hallucinations," where the AI generates incorrect or misleading information.
"The complexity of the models, including model architecture and the large corpus of data typical of GenAI models, can be a factor that leads to such hallucinations. Thus, while a potentially notable benefit of GenAI is that it can generate outputs that are applicable to a specific area of interest from a variety of different data types, or that it can generate outputs that are relevant to a broad number of tasks, GenAI can also present potential risks that may require varying levels of risk controls for different applications, as is true of other technologies," the FDA said in its executive summary about the Digital Health Advisory Committee meeting this week.
The medtech industry is poised to benefit significantly from GenAI-enabled devices. Applications range from administrative support, such as automating documentation, to advanced clinical tools capable of diagnosing diseases or personalizing treatment plans. GenAI can potentially improve healthcare efficiency and accessibility, particularly in underserved areas, according to the FDA.
However, the FDA's summary highlights several concerns. GenAI models often rely on datasets that are too large or complex for developers to analyze fully, raising questions about data bias, reproducibility and ethical considerations. The evolving nature of these technologies also complicates traditional regulatory approaches. Foundation models used in GenAI may not have been designed with medical applications in mind, creating additional hurdles for ensuring their safety and reliability.
The FDA proposes a TPLC regulatory framework tailored to GenAI-enabled devices. This lifecycle approach includes:
The FDA's effort to regulate GenAI-enabled devices underscores the broader challenge of integrating advanced AI into healthcare. It represents a significant shift in how medical devices are designed, deployed and monitored, requiring a rethinking of traditional regulatory approaches.
The federal agency acknowledges the need for updated regulatory pathways that account for GenAI's dynamic capabilities while maintaining patient safety. Stakeholders hope this meeting will provide clarity for manufacturers navigating an evolving regulatory landscape.
As interest in GenAI grows across the healthcare sector, the FDA's approach could set a precedent for the safe adoption of these technologies. The outcome of this week's meeting may shape the future of medtech innovation, offering pathways to unlock the potential of AI-driven devices while safeguarding public health.