Predetermined Change Control Plan
FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices.
Definition
A Predetermined Change Control Plan (PCCP) is a document, included in a marketing submission, that describes planned modifications to an AI/ML-enabled device, the methods used to develop, validate, and implement those modifications, and the impact on the device.What this means in practice
PCCPs let manufacturers update AI/ML models within an authorized envelope without a new submission, while preserving safety and effectiveness controls.Use cases
1 scenarioContinuous learning chest-X-ray triage SaMD
ML & RA teamThe sponsor includes a Predetermined Change Control Plan in the 510(k): allowed modifications (retraining cadence, new sites), the protocol (data governance, performance thresholds), and impact assessment.
Cross-references
Related terms
Shared paths + categoryGuiding principles for the development of AI/ML-enabled medical devices.
Software intended for medical purposes that performs without being part of a hardware device.
Software providing healthcare professionals with knowledge and patient-specific information.
Software embedded in or required to operate a hardware medical device.
Software not developed for medical device use, or lacking adequate development records, incorporated into a device.
IEC 62304 classes A, B, C reflecting potential harm from software failure.
Latest in MedTech
Primary references
3 sources- 1FDA PCCP GuidanceVerifiedFDAfda.gov
- 2FDA - AI/ML-Enabled Medical DevicesVerifiedFDAfda.gov
- 3IMDRF - Software as a Medical DeviceVerifiedIMDRFimdrf.org
Inline markers like [1] jump to the matching reference above.