We’re considering how an approach that enables the evaluation and monitoring of a software product from its premarket development to post-market performance could provide reasonable assurance of safety and effectiveness and allow the FDA’s regulatory oversight to embrace the iterative nature of these artificial intelligence products while ensuring that our standards for safety and effectiveness are maintained. This first step in developing our approach outlines information specific to devices that include artificial intelligence algorithms that make real-world modifications that the agency might require for premarket review. They include the algorithm’s performance, the manufacturer’s plan for modifications and the ability of the manufacturer to manage and control risks of the modifications.

The agency may also intend to review what’s referred to as software’s predetermined change control plan. The predetermined change control plan would provide detailed information to the agency about the types of anticipated modifications based on the algorithm’s re-training and update strategy, and the associated methodology being used to implement those changes in a controlled manner that manages risks to patients. Consistent with our existing quality systems regulation, the agency expects software developers to have an established quality system that is geared towards developing, delivering and maintaining high-quality products throughout the lifecycle that conforms to the agency’s standards and regulations.


The goal of the framework is to assure that ongoing algorithm changes follow pre-specified performance objectives and change control plans, use a validation process that ensures improvements to the performance, safety and effectiveness of the artificial intelligence software, and includes real-world monitoring of performance once the device is on the market to ensure safety and effectiveness are maintained. We’re exploring this approach because we believe that it will enable beneficial and innovative artificial intelligence software to come to market while still ensuring the device’s benefits continue to outweigh it risks.

We have more work to do to build out this initial set of ideas and we’ll rely on comments and feedback from experts and stakeholders in this space to help inform the agency as we continue to think about how we’ll regulate artificial intelligence technologies to improve patient care. We anticipate several more steps in the future, including issuing draft guidance that’ll be informed by the feedback on today’s discussion paper.

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