FDA De Novo Classification Strategy

· Incorrect algorithm output

· User misunderstanding

· Cybersecurity threats

· Data integrity failures

· System downtime

· Incomplete data inputs

· Interface design errors

· Integration failures

· Cloud infrastructure interruptions

Each hazard underwent systematic evaluation using ISO 14971 principles.

Where risks could not be eliminated entirely, multiple layers of mitigation were implemented through software controls, user interface improvements, clinician training, validation testing, labeling, and ongoing monitoring.

This comprehensive approach demonstrated that foreseeable risks had been reduced as far as reasonably practicable.