General Principles of Software Validation; Final Guidance for Industry and FDA Staff
Document issued on: January 11, 2002
This document supersedes the draft document, "General Principles of Software Validation, Version 1.1, dated June 9, 1997.
U.S. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research
Guidance for Industry and FDA Staff
General Principles of Software Validation
Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance which involve the Center for Devices and Radiological Health (CDRH), contact John F. Murray at (301) 594-4659 or email email@example.com For questions regarding the use or interpretation of this guidance which involve the Center for Biologics Evaluation and Research (CBER) contact Jerome Davis at (301) 827-6220 or email firstname.lastname@example.org.
CDRH Additional copies are available from the Internet at: http://www.fda.gov/cdrh/comp/guidance/938.pdf or via CDRH Facts-On-Demand. In order to receive this document via your fax machine, call the CDRH Facts-On-Demand system at 800899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number 938 followed by the pound sign (#). Follow the remaining voice prompts to complete your request. CBER Additional copies are available from the Internet at:...