FDA guidance
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and…
FDA guidance · Draft · issued Jan 7, 2025
Key facts
| Title | Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff |
|---|---|
| Status | Draft |
| Issue date | Jan 7, 2025 |
| Center | Center for Devices and Radiological Health |
| Issuing office | Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Biologics, Drugs, Medical Devices |
| Topics | Postmarket, Premarket |
| Docket number | FDA-2024-D-4488 |
| Comments close | Apr 7, 2025 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- None Product codes referenced
- None Recognized standards referenced
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About FDA guidance documents
FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.
Source: U.S. Food and Drug Administration (FDA), Guidance Documents