Build future AI/algorithm updates into your cleared device without resubmitting every time — or revise an existing PCCP that FDA has questioned. Covers modification protocol, performance evaluation protocol, and labeling update methodology aligned to FDA and IMDRF guidance.
Build future AI/algorithm updates into your cleared device without resubmitting every time — or revise an existing PCCP that FDA has questioned. Covers modification protocol, performance evaluation protocol, and labeling update methodology aligned to FDA and IMDRF guidance.