What a Predetermined Change Control Plan (PCCP) Means for Your AI Device Team
What a PCCP includes
The FDA’s August 2025 final guidance on predetermined change control plans for AI-enabled device software functions recommends that a PCCP describe the planned modifications, the methods used to develop, validate, and implement them, and an assessment of their impact. FDA reviews the PCCP as part of a marketing submission. For changes covered by an authorized plan and carried out according to its methods, manufacturers generally do not need a separate marketing submission for each modification.
That makes the people who will carry out the plan part of product planning. A hiring team needs to decide who will define the planned changes, conduct the evaluations, document the results, and handle the release.
Assign ownership for planned changes
A PCCP touches several kinds of work. Regulatory affairs usually defines the plan’s scope and decides whether a proposed change falls inside it, with quality making sure the approved procedures are followed. Data and machine-learning specialists develop the update and run the specified evaluations. Software engineers handle version control, integration, verification, and release. Clinical experts confirm the evidence still fits the intended users and use context.
Example: a planned model retraining
Consider a startup with an authorized PCCP that covers retraining its model with new data from the same input type and intended-use population. The plan defines how the model will be retrained, evaluated, and assessed before implementation.
Regulatory affairs has to confirm each retraining stays within the authorized scope, and a clinical owner has to confirm the evidence still supports the intended use. Only one of those five owners builds models.
Keep the plan within its scope
A PCCP is not open-ended authorization for any future model change. It covers modifications FDA authorizes in the plan and the methods specified there. A change outside that scope, or one implemented inconsistently with the plan, needs to be evaluated under applicable device-modification requirements and may require another marketing submission. That makes scope judgment a hiring requirement. Regulatory affairs has to recognize when a proposed update goes beyond the plan, with quality supporting the review and ensuring the issue is documented before a change ships.
Hire before the submission, and plan for turnover
A PCCP is written as part of the marketing submission, so the people who design the modification protocol need to be on the team before it is filed. The plan also has to outlast them. Retraining under a PCCP can happen years later, sometimes by people who were not there when it was written. When hiring for these roles, look for candidates who document their work well enough for someone else to carry it out, and make sure the plan’s rationale lives in the quality system.
Use interviews to test controlled-change experience
When interviewing for PCCP-related roles, ask candidates to walk through a controlled change they managed:
What was the change, and what evidence supported releasing it?
How were risk and impact assessed?
How was the release decision documented?
For technical candidates, ask how they kept training and test data separated, and whether someone else could reproduce their results from their records. For quality and regulatory candidates, ask how they decided whether a change fit within its approved scope.
How JBL Resources can help
JBL Resources recruits the regulatory, quality, and medical device software professionals who make up the controlled side of AI-enabled device teams. For PCCP-related searches, we help hiring teams define how responsibility will be divided between regulatory oversight, technical execution, and quality records.
For more on scoping these roles from the start, see How to Build an AI Medical Device Team Around the Product’s Intended Use.
Planning future updates to an AI-enabled device? Download Hiring at the Intersection: A Practical Talent Guide to AI-Enabled Medical Device Software, or talk with our team about the roles your plan will need.
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