FDA De Novo Classification Strategy

· Risk management

· Quality management system implementation

· FDA interactions

· Cybersecurity planning

· Human factors engineering

· Post-market surveillance strategy

· Commercialization planning

This roadmap provided leadership with a clear sequence of activities and decision points, allowing technical, clinical, quality, and commercial teams to work toward common objectives.

Early Engagement with FDA

Recognizing the importance of obtaining regulatory feedback before finalizing development activities, E&E Medicals recommended participation in the FDA’s Q-Submission Program.

A detailed pre-submission package was prepared, describing the technology, proposed intended use, software architecture, machine learning methodology, risk analysis, planned verification testing, anticipated clinical evidence, and specific questions requiring FDA feedback.

The pre-submission meeting proved invaluable.