References for Biotech and Medical Device Companies

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References for Biotech and Medical Device Companies

Selected references from FDA are listed below. These are available from FDA or click on the document 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 Guidance for Off-the-Shelf Software Use in Medical Devices, Draft Guidance, dated August 17, 1998 ODE.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.
Recalled Part 11 Guidance Documents Guidance for Industry, 21 CFR Part 11 Electronic Records Electronic Signatures; Glossary of Terms, Draft, August 2001 FDA. Guidance for Industry, 21 CFR Part 11 Electronic Records Electronic Signatures; Validation, Draft, August 2001 FDA. Guidance for Industry, 21 CFR Part 11 Electronic Records Electronic Signatures; Time Stamps, Draft, February 2002 FDA. Guidance for Industry, 21 CFR Part 11 Electronic Records Electronic Signatures; Maintenance of Electronic Records, Draft, July 2002 FDA. Guidance for Industry, 21 CFR Part 11 Electronic Records Electronic Signatures; Electronic Copies of Electronic Records, Draft, August 2002 FDA.
Articles "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.

For further information,

call Steve Rakitin at 508.529.4282

or e-mail him at steve@swqual.com

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Updated January 2008