Knowledge Check: Data & Models

Test your understanding of data management, model documentation, and validation terminology in FDA's draft guidance.

Passing score: 70%

1. Test data used for FDA performance validation should be independent of and sequestered from model development data.

2. In FDA device submissions, 'validation' means:

3. Which data management topics should AI device submissions address? (Select all that apply)

Select all that apply

4. Why is a reference standard important in AI device submissions?