PCCP Aid
Build a defensible Predetermined Change Control Plan that earns the freedom to iterate post-clearance, without re-submitting for every model update.
Overview
PCCPs are the difference between a static device and a learning product. Done well, they let you retrain, recalibrate, and refine within a pre-agreed envelope. Done poorly, they collapse on first FDA review.
We translate your product roadmap into a PCCP that the FDA recognizes: clear modification boundaries, defensible acceptance criteria, and change qualification protocols that survive scrutiny.
Our Process
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1
Modification candidate inventory
What changes do you anticipate over the device lifetime?
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2
Boundary definition
Categorize each modification: within PCCP, outside PCCP, or borderline.
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3
Acceptance criteria
Per modification type, what evidence demonstrates safety and effectiveness?
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4
Change qualification protocol
How will modifications be qualified before deployment?
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5
Draft & review
Cycle drafts through regulatory counsel; align with FDA guidance.
Frequently Asked Questions
Does PCCP cover model retraining?
Yes, for AI/ML devices, this is often the central use case.
How does this interact with FDA's PCCP final guidance?
We align explicitly with the 2024 final guidance and the December 2024 examples.
Can existing devices add a PCCP retroactively?
Yes, via supplement. The path is more involved than including it at first submission.
What is the typical scope?
Most early PCCPs cover 4-8 modification categories. Going wider on first submission often delays clearance.
Earn the freedom to iterate.
Send us your product roadmap and current FDA posture. We will return a PCCP outline within four weeks.
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