FDA Pre-Sub Follow-Up Package (Draft)

Objective

Prepare a structured follow-up packet for FDA Pre-Submission feedback incorporation and De Novo planning.

1. Package Contents

• Product scope split document (wellness vs FDA-gated adaptive functions)
• IEC 62304 draft set:
• software requirements
• software architecture
• verification traceability matrix
• AI guardrail dossier and validation approach
• Risk-control narrative tied to feature gates

2. Key Claims Strategy

• Maintain wellness-only claims for currently marketed profile.
• Position adaptive behavior as gated, controlled, and not active in current commercial release.
• Define post-clearance activation path with documented verification and labeling changes.

3. Questions for FDA Follow-Up

1. Is proposed intended-use language appropriately scoped for software function classification?
2. Are guardrail and human-factors controls adequate for adaptive output risk profile?
3. Are traceability and verification artifacts sufficient at this stage for De Novo progression?
4. Any additional expectations for cloud-model lifecycle documentation and post-market surveillance?

4. Evidence Plan

• Summative verification report for gated/off behavior
• Design control mapping from requirements -> tests -> risks
• Prompt safety validation results and adverse-case handling outcomes
• Configuration management records for feature gate defaults

5. Milestones

• M1: Internal regulatory + engineering review of draft docs
• M2: Incorporate legal/claims review
• M3: Submit Pre-Sub follow-up packet
• M4: Integrate agency feedback into De Novo dossier

6. Owners

• Regulatory Lead: submission narrative, intended-use framing
• Engineering Lead: architecture and verification artifacts
• QA Lead: traceability evidence and test reproducibility
• Product Lead: claims-language parity across app + metadata