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Guidance Documents/Guidance-Document/Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff

Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

January 7, 2025

January 6, 2025

Center for Devices and Radiological Health

7498efae-e618-4d5c-948d-0ce31ebc65c6

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