No. QCC focuses on regulatory documentation and evidence packaging for review; algorithm development and proprietary optimization remain with the sponsor.
FDA 510(k) AI/ML Docs
Does QCC build or optimize AI/ML models?
What deliverables do you provide?
Deliverables may include submission-ready AI/ML documentation packages, reviewer-focused narratives explaining data and performance, risk-based rationale for controls, and traceability matrices linking evidence to submission sections.
What inputs do you typically need from a sponsor?
Typical inputs include model purpose and architecture descriptions, data documentation for training/validation, performance results, identified risks and controls, and any internal evaluation artifacts relevant to claims and limitations.
Who is FDA 510(k) AI/ML documentation support intended for?
This service supports sponsors developing AI/ML-enabled medical devices (including SaMD), preparing a 510(k) submission where AI/ML functionality is part of the intended use, performance claims, or risk profile.