We prepare a comprehensive, FDA-ready Interaction & Defense Support Plan for direct internal use across PMA, 510(k), De Novo, IND/IDE, AI/ML SaMD, CDx, NGS, or clinical trial interactions.
“We de-risk AI healthcare products by designing regulatory-approvable AI systems and pre-empting FDA review failures.”
Purpose: Survive Pre-Subs, Interactive Review, and Panels.
Deliverables:
- Pre-Sub briefing package (AI-focused)
- Mock FDA deficiency letters
- Reviewer-style Q&A scripts
- Advisory panel defense slides
- Response drafting support
Duration: As needed