Knowledge Check: Submissions Content

Test your understanding of FDA's draft recommendations for device description, labeling, and risk assessment.

Passing score: 70%

1. Which elements should an AI device description include? (Select all that apply)

Select all that apply

2. Why does FDA emphasise information-related risks for AI devices?

3. AI device labeling should include subgroup performance and known limitations when applicable.

4. Which standards does FDA recommend for AI device risk management files?