FDA issues final guidance on postmarket updates to AI-enabled devices

The US Food and Drug Administration (FDA) has issued a much-anticipated final guidance document detailing how it plans to regulate changes to artificial intelligence (AI) enabled medical devices post authorization by using pre-determined change control plans (PCCPs), allowing manufacturers to update AI-enabled devices without filing an additional submission to the Agency. The document is titled ‘Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff’.

The FDA first introduced the concept of PCCPs in a 2019 discussion paper about modifications to AI- or machine learning-based devices. Currently, devices on the market that use AI or machine learning are ‘locked’, meaning the algorithm cannot adapt or change over time without requiring a new filing. PCCPs are meant to solve this problem by allowing for performance enhancements through iterative changes, with manufacturers sharing a framework for proposed device modifications as part of the initial premarket submission to the FDA. The final guidance is largely consistent with the draft published in 2023 but includes a new section on version control and maintenance.

PCCPs should give device manufacturers more leeway to update AI-enabled devices, but those changes must stay within certain limitations consistent with the PCCP without any changes to a device’s intended use.

The guidance states that a PCCP should include three components:

• a description of planned modifications,
• a modification protocol explaining the criteria for how manufacturers will determine a device remains safe and effective with the planned changes, and
• an impact assessment that details the benefits and risks of the PCCP as well as risk mitigation plans.