FDA De Novo Classification Strategy

· Product functionality

· Software architecture

· Machine learning methodology

· Clinical workflow integration

· Risk profile

· Existing FDA product codes

· Historical De Novo decisions

· Relevant guidance documents

· Consensus standards

· Similar marketed technologies

· International regulatory classifications

Rather than focusing solely on technical similarities, E&E Medicals evaluated whether existing products addressed the same clinical questions and whether their technological differences could introduce new issues of safety or effectiveness.