We prepare a strategy that defines the global regulatory pathway for an Artificial Intelligence / Machine Learning–enabled Software as a Medical Device (AI SaMD), from early development through post-market lifecycle management. It is intended to:
- Establish the appropriate regulatory classification and submission pathway
- Align development activities with FDA, IMDRF, and international expectations
- De-risk regulatory review by anticipating the FDA reviewer’s focus areas
- Enable scalable model updates through a Predetermined Change Control Plan (PCCP)
Purpose: Prevent wrong pathway selection (fatal error).
Deliverables
- Intended Use & claims risk calibration
- FDA pathway decision (510(k) vs De Novo vs PMA)
- AI risk classification
- Regulatory timeline & evidence roadmap
- Competitor predicate/reference mapping
Duration: 2–4 weeks