FDA guidance
Application User Fees for Combination Products: Guidance for Industry and FDA Staff
FDA guidance · Final · issued Jul 16, 2024
Key facts
| Title | Application User Fees for Combination Products: Guidance for Industry and FDA Staff |
|---|---|
| Status | Final |
| Issue date | Jul 16, 2024 |
| Center | Office of the Commissioner |
| Issuing office | Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products |
| Communication type | Guidance Document |
| Regulated product | Biologics, Drugs, Medical Devices |
| Topics | User Fees |
| Docket number | FDA-2004-D-0371 |
| 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