Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

TitleGuidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
ToC Doc Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
Docket Number2024-28361
Type Notice
Subject Guidance:
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
Publication Date2024-12-04
Last Updated Date 2024-12-03 08:15:13 -0500
Last Public Inspection2024-12-03
Filed At2024-12-03T08:45:00.000-05:00
PDF 2024-28361_PI.pdf (85024 bytes)
Download TXT / HTML / JSON
Number of Pages 8
Filing Typeregular
AgenciesFood and Drug Administration

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