FDA guidance
Computer Software Assurance for Production and Quality System Software: Guidance for…
FDA guidance · Final · issued Sep 24, 2025
Key facts
| Title | Computer Software Assurance for Production and Quality System Software: Guidance for Industry and Food and Drug Administration Staff |
|---|---|
| Status | Final |
| Issue date | Sep 24, 2025 |
| Center | Center for Devices and Radiological Health |
| Communication type | Guidance Document |
| Topics | Postmarket |
| Docket number | FDA-2022-D-0795 |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- 1–9 Product codes referenced
- 1–9 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