# Regulations.gov document: Reference 2 - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions — retained record

> Retained regulations record from regulations-gov.

Canonical: https://highsignal.app/data/records/2661730da4854646

[← sources](https://highsignal.app/data)


source: [regulations](https://highsignal.app/data/regulations) (regulations-gov)  published 2026-08-17 04:00 ingested 2026-08-18 06:29

[original source ↗](https://www.regulations.gov/document/FDA-2025-N-1243-0024)

## extract

Query: cybersecurity
Agency: FDA
Type: Supporting & Related Material
Docket: FDA-2025-N-1243

## retained text



```
Query: artificial intelligence
Agency: FDA
Type: Supporting & Related Material
Docket: FDA-2025-N-1243
```



document fetched 2026-09-03 02:45 · canonical https://regulations.gov/document/FDA-2025-N-1243-0024