Findings
AI-DSFs undergo iterative improvements, necessitating a structured framework for modifications to ensure safety and effectiveness.
PCCPs enable manufacturers to streamline modifications by avoiding repeated marketing submissions, reducing regulatory burden.
Critical elements of a PCCP include data management practices, re-training protocols, performance evaluation, and user update procedures.
Comprehensive risk management and transparency are essential to address potential biases and maintain user trust.
Certain modifications, such as those significantly affecting safety or effectiveness, may still require a new marketing submission.

Recommendations
Structure PCCPs with a clear description of planned modifications, a detailed modification protocol, and a robust impact assessment.
Include methods for data collection, re-training, and performance evaluation aligned with quality system regulations.
Specify user update procedures to communicate changes transparently and ensure safe device use.
Address cybersecurity risks and bias mitigation strategies in modification protocols.
Use the FDA Q-Submission Program to discuss PCCPs prior to submitting marketing applications for AI-DSFs.

Regulatory Considerations
Adherence to 21 CFR Part 820 Quality System Regulations, including design controls and risk management.
PCCPs must include modifications that would otherwise require a PMA supplement or new 510(k) submission.
Modifications implemented under PCCPs must conform to FDA-reviewed protocols and be documented in the device master record.
Transparency to users via device labeling updates and public summaries of authorized PCCPs is required.
Modifications outside the scope of an authorized PCCP or deviations from the protocol require new FDA marketing submissions.