Issue Date: January 11, 2002
Issued by: Center for Biologics Evaluation and Research
Topic(s): Premarket, Digital Health, Good Clinical Practice (GCP)
Status: Final
General Principles of Software Validation: Guidance for Industry and FDA Staff
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.
Download the Guidance Document
