Predetermined Change Control Plans in AI Devices Submitted to FDA
When companies submit medical devices to the FDA, both parties expect some iteration. As the use of AI enabled technologies in medical care increases, the existing regulatory paradigm becomes less well-tailored. One way to keep on top of ongoing regulatory changes - whether automatic updates or manual - is to submit Predetermined Change Control Plans. PCCPs are documents that describe what changes the sponsor intends to make over time, the effect of those changes on the performance of the device and the methodology by which the sponsor will implement these changes.
FDA released final guidance on PCCPs for AI enabled device software functions on December 4. The guidance outlines recommendations for PCCPs so that sponsors do not need to continue providing submissions for each update.
The guidance includes a number of useful definitions, including
Artificial Intelligence: AI is a machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations, or decisions influencing real or virtual environments.
Machine Learning: ML, a subset of AI, is a set of techniques that can be used to train AI algorithms to improve performance at a task based on data.
PCCP: The documentation describing what modifications will be made to a device and how the modifications will be assessed. The modifications described in the PCCP include device modifications that would otherwise require a PMA supplement or new premarket notification. These modifications include those that could significantly affect, or that otherwise affect, the safety or effectiveness of the device, unless those modifications are covered by an authorized PCCP.
FDA recommends that a PCCP include (1) a Description of Modifications; (2) the Modification Protocol, and (3) an Impact Assessment.
The Description of Modifications should include information on what will change, why, and how. For example, changing the number of events that qualify as flagging a problem for a wearable; and that it will be implemented automatically.
The Modification Protocol should include the processes for changes - what are the types of data or testing that will be required? How will the company record and store the information supporting the change? For example, adding a variant to a genetic test panel includes validating the accuracy of the test device with other test methods. This section also includes labeling updates.
The Impact Assessment should include information sharing the risks and benefits of implementing the PCCP. Not only should this cover each individual potential change, but any cumulative over overlapping changes.
Of note, the guidance reminds readers that a moderate risk device amended consistent with a PCCP can be a predicate device for other 510(k) submissions (Brendan has a good image explaining this on his blog. He also has links to existing products with PCCPs so folks can get a sense of the content and format).
The guidance also includes examples of PCCPs and questions that should be answered before submission. The FDA urges sponsors to utilize the Q-submission process to get feedback in advance of submission.