FDA Announces Action Plan For AI- And Machine Learning-Based Software As A Medical Device

As technology continues to evolve, so should the regulations for its usage. The Food and Drug Administration (FDA) claims that artificial intelligence and machine learning have the potential to better healthcare quality, and recently announced an Artificial Intelligence and Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan.

This plan looks to support and regulate developing frameworks and determine when they are used. The FDA also described a “Predetermined Change Control Plan” in which anticipated that modifications and patient risks will be managed in a controlled manner and referred to as the “Algorithm Change Protocol.”

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Through this plan, the FDA and manufacturers look to observe and evaluate real world performance.  The FDA expects a transition once the software is placed on the market and has developed a plan that allows healthcare providers and patients to view the development through the distribution process.

In the past, the FDA's medical device reviewing process had not been designed for AI/ML. This call to action is a response to feedback from its agency’s April 2019 discussion paper, “Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device.”

The framework will focus primarily on developing the proposed regulatory framework, improving machine learning algorithms, ensuring device transparency and patient experience, and monitoring real-world performance.

The FDA looks to harness the potential of AI/ML in the healthcare industry, pulling from new discoveries in information used every day. The software will enable manufacturers to develop and improve their products while providing patients with accurate and modern results. Some areas that have already integrated AI/ML include chronic disease management, medical imaging, and the Internet of things. By incorporating modern software, machines are able to detect irregular heartbeats, improve medical scan image clarity, and better protocol outcomes.

The FDA's goal is to develop a modern framework for the new software and observed premarket results.  Through these trials, patient safety and total product lifecycle will be evaluated before the transition that is anticipated post-market. The FDA will continue pursuing updated software in its mission to develop and apply innovative approaches to the regulations for new products.