level of concern description #7
Description
Formal document to agree on de novo, basic risks and hazards, and regulatory pathway with FDA.
See #2 for more info.
Can be short, few pages, needs:
- background of apps/software
- agreement on basic risks
- agreement on which regulations to satisfy/how
- de novo with special controls
- develop plan/roadmap to assemble review supporting materials towards approval, with joint plan on maintaining compliance and record keeping