Knowledge Check: FDA AI Device TPLC Introduction

Test your understanding of FDA's draft TPLC scope, key definitions, and how this guidance relates to GMLP and PCCP.

Passing score: 70%

1. FDA's January 2025 AI device TPLC document is draft guidance and is not legally binding.

2. What is an AI-enabled device software function (AI-DSF)?

3. What is a Predetermined Change Control Plan (PCCP)?

4. In FDA medical device submissions, 'validation' should NOT refer to: