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Selected FDA regulations, guidance documents and articles

Selected references from FDA are listed below. These are available from FDA.gov or you can click on a document below to download a PDF version.

Regulations

• 21 CFR 820, Current GMP, Final Rule, October 7, 1996 FDA.
• 21 CFR Part 11, Electronic Records Electronic Signatures, Final Rule, March 20, 1997 FDA.

Guidance Documents

• Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, May 11, 2005 CDRH, CBER.
• General Principles of Software Validation, FINAL Guidance, dated January 11, 2002 CDRH.
• Guidance for Off-the-Shelf Software Use in Medical Devices, Draft Guidance, dated August 17, 1998 ODE.
• Guidance for Industry Computerized Systems Used in Clinical Trials, Sept 2004 FDA.
• Guidance for the Content of Pre-market Submission for Medical Devices Containing Software, Final, May 29, 1998 ODE.
• Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997 CDRH.
• Do It By Design, A Guide to Human Factors in Medical Device Design, January 1997 FDA.

Part 11 Guidance Documents

• Guidance for Industry, 21 CFR Part 11 Electronic Records Electronic Signatures; Scope and Application, Draft, February 2003 FDA.

Articles

• "Networked Medical Devices: Essential Collaboration for Improved Safety", by Steven R. Rakitin, AAMI BI&T, Vol. 43, No. 4, July-Aug 2009, p.332-338.
• "Coping with Defective Software in Medical Devices", by Steven R. Rakitin, IEEE Computer, April 2006.
• "An Investigation of the Therac-25 Accidents", by Nancy Leveson and Clark Turner, IEEE Computer, July 1993.