# General Principles of Software Validation:  Guidance for Industry and FDA Staff – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/general-principles-of-software-validation-guidance-for-industry-and-fda-staff/e7963bfa-d95d-492f-8cb0-09d90a9c9535

> FDA guidance document: General Principles of Software Validation:  Guidance for Industry and FDA Staff. Issue date: January 11, 2002. Get complete insights and analysis.

---

## Details

- Title: General Principles of Software Validation:  Guidance for Industry and FDA Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2002-01-11
- Last Changed: 2025-09-23
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1997-D-0029">FDA-1997-D-0029</a>

## Related Documents

- [Software as a Medical Device (SAMD): Clinical Evaluation:  Guidance for Industry and Food and Drug Administration Staff](https://www.keypedia.com/guidances/guidance-document/software-as-a-medical-device-samd-clinical-evaluation-guidance-for-industry-and-food-and-drug-administration-staff/745234d9-1b52-4aa1-aff4-297a93f801f8)
- [Medical Glove Guidance Manual:  Guidance for Industry and FDA Staff](https://www.keypedia.com/guidances/guidance-document/medical-glove-guidance-manual-guidance-for-industry-and-fda-staff/d2548566-4793-4a0b-91d0-d16f13c97188)
- [Medical Device Reporting for Manufacturers :  Guidance for Industry and Food and Drug Administration Staff](https://www.keypedia.com/guidances/guidance-document/medical-device-reporting-for-manufacturers-guidance-for-industry-and-food-and-drug-administration-staff/bdf0f904-24f2-44f0-8046-74c1e429237a)