FDA De Novo Classification Strategy

· Version control

· Change management

· Software lifecycle documentation

· Cybersecurity protections

· Human oversight mechanisms

Although the software incorporated machine learning techniques, E&E Medicals ensured that clinical users remained responsible for final medical decisions, reinforcing the system’s role as a decision-support tool.

Clinical Evidence Development

Because no predicate existed, robust clinical evidence became especially important.

E&E Medicals collaborated with physicians, statisticians, software developers, and clinical operations specialists to develop an evidence-generation strategy capable of demonstrating both safety and effectiveness.

Clinical evaluations were designed to answer practical regulatory questions rather than simply demonstrate technical performance.

Investigators evaluated:

· Algorithm accuracy