What Is a Predetermined Change Control Plan (PCCP)? FDA Guide

Why the PCCP Framework Exists

AI/ML-enabled device software functions are typically updated through retraining or recalibration as new data becomes available. Under standard FDA pathways, a modification that changes device performance, algorithm logic, or intended inputs can trigger a new marketing submission. This creates friction for manufacturers who need to update models iteratively without submitting each change for separate review.

The PCCP mechanism addresses this by allowing a manufacturer to describe, in advance, the specific modifications it intends to make, the methods it will use to validate those modifications, and the risks those modifications introduce. FDA reviews and authorizes this plan as part of the original marketing submission. Once authorized, modifications executed according to the plan are considered part of the cleared or approved device and do not require separate submission.

This approach reflects the total-product-lifecycle concept first introduced in FDA's 2021 AI/ML-Based SaMD Action Plan, which anticipated that AI/ML devices would need a lifecycle-oriented regulatory model rather than a single point-in-time clearance.

The Three Required Components

FDA's December 2024 final guidance specifies that a PCCP must contain three components, and each serves a distinct function in the review process.

Description of Modifications

The Description of Modifications identifies the specific changes the manufacturer intends to make, including performance characteristics or input specifications that may be modified. This section defines the boundary of what is authorized. Any change outside this description falls outside the PCCP and requires a new submission.

Modification Protocol

The Modification Protocol describes how the manufacturer will implement each described modification. This includes data management practices for training, tuning, and test datasets, the retraining methodology, and the performance evaluation methods and acceptance criteria used to confirm the modification meets predefined standards before deployment.

Impact Assessment

The Impact Assessment evaluates the benefits and risks introduced by the planned modifications and describes the mitigations the manufacturer will apply. FDA expects this assessment to be revisited if cumulative changes shift the device's risk profile beyond what was originally evaluated.

Operational Obligations After Authorization

Authorization of a PCCP does not remove ongoing regulatory obligations. Manufacturers remain subject to FDA's Quality System Regulation and Quality Management System Regulation requirements, and the PCCP itself must be operationalized through internal processes that connect regulatory commitments to actual engineering practice.

This requires governance review before any modification is deployed, confirming that the change falls within the authorized Description of Modifications and was validated according to the Modification Protocol. It also requires documentation systems capable of retaining evidence that each deployed change matches the authorized plan, since this evidence is what supports continued compliance during FDA inspection.

Post-deployment, manufacturers are expected to monitor real-world performance to detect drift or degradation relative to the acceptance criteria defined in the protocol. Where monitoring identifies performance outside authorized boundaries, the modification is no longer covered by the PCCP and may require escalation, rollback to a previously validated version, or a new marketing submission depending on the severity and nature of the deviation.