Knowledge Check: Monitoring & Cybersecurity

Test your understanding of performance validation, postmarket monitoring, transparency, and cybersecurity in FDA's draft AI device guidance.

Passing score: 70%

1. Why does FDA emphasise postmarket performance monitoring for AI devices?

2. According to FDA and GMLP, when should human–device team performance be evaluated?

3. Which are AI-specific cybersecurity risks FDA highlights? (Select all that apply)

Select all that apply

4. FDA recommends addressing transparency and bias only after a device is marketed.