About This File
- Docket Number: FDA-1997-D-0029
- Issued by: Center for Devices and Radiological Health
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Center for Biologics Evaluation and Research
This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0, supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997.