CLAIM-2026-08-12-08

The FDA's final guidance 'Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions' provides that a Predetermined Change Control Plan must describe the planned device modifications, the associated methodology to develop, validate and implement those modifications, and an assessment of the impact of those modifications.

Why it matters

A worked example of what a pre-authorised change envelope looks like when a regulator specifies one in full, offered as a contrast to the single clause in Article 43(4).

Sources

• usfoodanddr2025marketing