FDA Guidance on PCCP for AI-Enabled Devices
The FDA's guidance provides recommendations for manufacturers submitting marketing applications for AI-enabled devices that include a predetermined change control plan (PCCP). AI-DSFs are software functions that use artificial intelligence or machine learning to assist in clinical or operational decision-making.
Key Elements of a PCCP
The guidance also highlights key elements of a PCCP, including how to assess the impact of changes on safety and effectiveness, validation procedures for any modifications, and criteria for implementing changes without needing a new marketing submission.
- Device Description – An overview of the AI-DSF, its intended use, and key performance characteristics.
- Predetermined Change Control Plan – A detailed plan describing anticipated software changes, associated risks, validation approaches, and how changes will be implemented.
- Risk Management Documentation – Analysis of potential risks from planned changes and how they will be mitigated.
- Data Management and Algorithm Updates – Processes for data collection, retraining, validation, and performance monitoring.
- User Interface and Labeling – Clear instructions to ensure the device is used safely and effectively.
- Cybersecurity Measures – Steps to protect device functionality during and after updates.
- Validation Reports – Evidence showing that planned changes will not compromise device safety or effectiveness.
Benefits of a Structured PCCP
Following these recommendations helps manufacturers prepare complete and reliable marketing submissions. A PCCP provides a structured framework for software updates, ensuring that AI-enabled devices continue to operate safely and effectively while allowing for predictable evolution over time.
Moving Forward
By adopting the FDA's PCCP recommendations, manufacturers can accelerate innovation, streamline regulatory submissions, and maintain trust with end users.
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