Keeping Up with AI and Machine Learning
New FDA draft guidance on AI-enabled devices will help manufacturers navigate a rapidly transforming landscape
Artificial intelligence (AI) continues to transform almost every sector of life, and the medical device industry is no exception. Medical device manufacturers are using AI and machine learning (ML) technologies to improve their devices to better assist medical professionals and patients in their care, and the FDA is adapting to provide guidance on these transformative tools.
The benefits of AI and machine learning
Machine learning is defined by the FDA as a set of techniques that can be used to train AI algorithms. AI and ML technologies can improve their performance by learning from real-world experiences, acquiring new and valuable insights from healthcare data collected daily.
According to the FDA, AI and ML technologies can be applied to medical devices in these areas:
- image and acquisition processing
- early disease detection
- more accurate diagnosis, prognosis and risk assessment
- identification of new patterns in human physiology and disease progression
- development of personalized diagnostics
- and therapeutic treatment response monitoring.
Keeping up with progress
On the other hand, AI and ML technologies present regulatory gaps and challenges, such as “a lack of methods to analyze training and test methods to understand, measure and minimize bias.” Other gaps include gathering metrics of performance estimation and evaluating safety and effectiveness of AI algorithms.
The FDA notes that its process of reviewing medical devices was not designed for adaptive AI and ML technologies. That’s why the organization continues to collaborate with academia, health care providers and other government agencies to publish research on AI and ML technologies and update regulations. On January 6, 2025, the FDA published the Draft Guidance: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. This draft guidance outlines lifecycle considerations and recommendations to assist manufacturers on AI-enabled devices.
AI is transforming our healthcare system, and ASG is dedicated to delivering safe and effective medical devices to our partners and patients. As these technologies keep evolving, we keep at monitoring AI-related innovations along with the regulations and recommendations established by the FDA.
If you’re interested in learning more about this topic, visit the FDA’s website.
