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# A Complete Guide to the FDA’s AI/ML Guidance for Medical Devices

**Lee Chickering**  
**February 20, 2025**

Artificial intelligence (AI) and machine learning (ML) technologies are rapidly transforming healthcare by extracting critical insights from the enormous amounts of data generated in the healthcare sector daily. These technologies are [driving innovation in medical devices](/content/use-case/ai-ml-med-device/index.html), enhancing their ability to support healthcare providers and improve patient outcomes. The ever-evolving nature of AI development, deployment, and maintenance demands stringent change management throughout the entire product lifecycle. The FDA has been proactive in pushing the industry towards safe AI/ML practices.

In this article, we will cover the most significant publications the FDA has released on AI/ML-enabled medical devices and provide a summary of each publication.

## **Understanding Artificial Intelligence and Machine Learning in Medical Devices**

AI refers to computational systems capable of making predictions, recommendations, or decisions that influence real or virtual environments based on a set of human-defined objectives. These systems utilize a combination of machine- and human-derived inputs to perceive environments, abstract these perceptions into models through automated analysis, and use these models to generate options for action or information.

Machine learning, a subset of AI, comprises techniques used to train AI algorithms, enabling them to improve their performance on specific tasks through data exposure.

Examples of AI and ML in healthcare include:

- **Diagnostic Imaging**: AI-powered imaging systems that provide diagnostic insights for conditions like skin cancer (companies like [DeepHealth/RadNet](/content/case-studies/deephealth-case-study/index.html)).
- **Predictive Analytics**: Smart devices that estimate the likelihood of cardiovascular events, such as heart attacks.

## **Transforming Medical Devices with AI and ML**

AI and ML technologies are revolutionizing healthcare by providing new insights from daily healthcare data. Medical device manufacturers are leveraging these technologies to innovate and improve their products, thereby enhancing patient care. A significant advantage of AI/ML-based software is its capacity to learn from real-world usage, continually refining and enhancing its performance over time.

## **FDA's Regulatory Approach to AI/ML-Enabled Medical Devices**

The FDA evaluates medical devices through various premarket pathways, including premarket clearance (510(k)), De Novo classification, and premarket approval. The agency also reviews modifications to existing devices, particularly when these involve software, to ensure that changes do not increase the risk to patients.

Traditional FDA regulatory frameworks were not initially designed for the adaptive nature of AI/ML technologies. As a result, the FDA has identified that many modifications to AI/ML-driven devices may require premarket review.

## **Key FDA AI Guidance Publications**

- **April 2019**: “ [Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device (SaMD)](https://www.fda.gov/files/medical%20devices/published/US-FDA-Artificial-Intelligence-and-Machine-Learning-Discussion-Paper.pdf)”.
- **January 2021**: “ [AI/ML SaMD Action Plan](https://www.fda.gov/media/145022/download)”.
- **October 2021**: “ [Good Machine Learning Practice for Medical Device Development: Guiding Principles](https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles)”.
- **April 2023:** “ [Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles](https://www.fda.gov/medical-devices/software-medical-device-samd/predetermined-change-control-plans-machine-learning-enabled-medical-devices-guiding-principles)”.
- **June 2024:** “ [Transparency for Machine Learning-Enabled Medical Devices](https://www.fda.gov/medical-devices/software-medical-device-samd/transparency-machine-learning-enabled-medical-devices-guiding-principles)”.
- **August 2024:** “ [Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/predetermined-change-control-plans-medical-devices)”.
- **December 2024:**