# Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/marketing-submission-recommendations-for-a-predetermined-change-control-plan-for-artificial-intelligence-enabled-device-software-functions-guidance-for-industry-and-food-and-drug-administration-staff/29b4b7c8-45f6-478c-bb72-f39ffd88cc9a

> FDA guidance document: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions:  Guidance for Industry and Food and Drug Administration Staff. Issue date: August 18, 2025. Get complete insights and analysis.

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## Details

- Title: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions:  Guidance for Industry and Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2025-08-18
- Last Changed: 2025-08-18
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2022-D-2628">FDA-2022-D-2628</a>

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