FDA’s New Draft Guidance on Predetermined Change Control Plans (PCCPs)

The FDA’s new draft guidance on Predetermined Change Control Plans (PCCPs) allows medical device manufacturers to obtain advance approval for specific, planned device modifications. The purpose of FDA’s new draft guidance on Predetermined Change Control Plans (PCCPs) is to improve regulatory efficiency while ensuring patient safety and compliance.

A Predetermined Change Control Plan (PCCP) enables manufacturers to pre-define updates such as algorithm improvements, user interface changes, data input modifications, material updates, or labeling revisions. Once approved under the FDA’s new draft guidance on Predetermined Change Control Plans (PCCPs), these changes can be implemented without submitting a new premarket application each time.

This framework is particularly beneficial for AI/ML-based Software as a Medical Device (SaMD), where frequent updates are expected. By following the FDA’s new draft guidance on Predetermined Change Control Plans (PCCPs), manufacturers can reduce regulatory burden, accelerate innovation, and maintain continuous safety and performance monitoring.