FDA guidance
General Principles of Software Validation: Guidance for Industry and FDA Staff
FDA guidance · Final · issued Jan 11, 2002
Key facts
| Title | General Principles of Software Validation: Guidance for Industry and FDA Staff |
|---|---|
| Status | Final |
| Issue date | Jan 11, 2002 |
| Center | Center for Devices and Radiological Health |
| Issuing office | Center for Biologics Evaluation and Research, Center for Devices and Radiological Health |
| Communication type | Guidance Document |
| Regulated product | Biologics, Medical Devices |
| Topics | Premarket |
| Docket number | FDA-1997-D-0029 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- 10–99 Product codes referenced
- 10–99 Recognized standards referenced
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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