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<b>References for Biotech and Medical Device Companies</b> </font>
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Selected references from FDA are listed below. These are available from
<A HREF="http://www.fda.gov/cdrh/">FDA</a> or click on the document to download a PDF version.
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<b> <u>Regulations </u></b></font>
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<li><A HREF="QSR.pdf">
21 CFR 820, Current GMP, Final Rule, October 7, 1996 FDA.
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<li><A HREF="Part11.pdf">
21 CFR Part 11, Electronic Records Electronic Signatures, Final Rule, March 20, 1997 FDA.
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<b><u>Guidance Documents </u></b></font>
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<li><A HREF="premarket.pdf">
Guidance for the Content of Premarket Submission for Software Contained in Medical Devices,
May 11, 2005 CDRH, CBER.
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<li><A HREF="GPSV.pdf">
General Principles of Software Validation, FINAL Guidance, dated January 11, 2002 CDRH.
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<li><A HREF="ots.pdf">
Guidance for Off-the-Shelf Software Use in Medical Devices, Draft Guidance, dated August 17, 1998
ODE.
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<li><A HREF="trials.pdf">
Guidance for Industry Computerized Systems Used in Clinical Trials, Sept 2004 FDA.
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<li><A HREF="510k.pdf">
Guidance for the Content of Pre-market Submission for Medical Devices Containing Software, Final,
May 29, 1998 ODE.
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<li><A HREF="design.pdf">
Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997 CDRH.
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<li><A HREF="Humanfactors.pdf">
Do It By Design, A Guide to Human Factors in Medical Device Design, January 1997, FDA.</a><p>
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<b><u>Part 11 Guidance Documents </u></b></font>
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<li><A HREF="Part11Scope.pdf">
Guidance for Industry, 21 CFR Part 11 Electronic Records Electronic Signatures; Scope and
Application, Draft, February 2003 FDA.
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<b><u>Recalled Part 11 Guidance Documents </u></b></font>
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<li><A HREF="Part11Glossary.pdf">
Guidance for Industry, 21 CFR Part 11 Electronic Records Electronic Signatures; Glossary of Terms,
Draft, August 2001 FDA.
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<li><A HREF="Part11Validation.pdf">
Guidance for Industry, 21 CFR Part 11 Electronic Records Electronic Signatures; Validation, Draft,
August 2001 FDA.
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<li><A HREF="Part11timestamps.pdf">
Guidance for Industry, 21 CFR Part 11 Electronic Records Electronic Signatures; Time Stamps,
Draft, February 2002 FDA.
</a><p>
<li><A HREF="Part11Maintenance.pdf">
Guidance for Industry, 21 CFR Part 11 Electronic Records Electronic Signatures; Maintenance of
Electronic Records, Draft, July 2002 FDA.
</a><p>
<li><A HREF="Part11Copies.pdf">
Guidance for Industry, 21 CFR Part 11 Electronic Records Electronic Signatures; Electronic Copies
of Electronic Records, Draft, August 2002 FDA.
</a><p>
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<b> <u>Articles </u></b></font>
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<ul type=bullet>
<li><A HREF="Defective.pdf">
"Coping with Defective Software in Medical Devices"</a>, by Steven R. Rakitin, IEEE Computer,
April 2006.
<p>
<li><A HREF="Therac25.pdf">
"An Investigation of the Therac-25 Accidents"</a>, by Nancy Leveson and
Clark Turner, IEEE Computer, July 1993.<p>
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<b>For further information,
<p>call Steve Rakitin at <font size="3" color=Red face="Arial">508.529.4282</font>
<p><font size="3" color=Black face="Arial">or e-mail him at
<a href="mailto:[email protected]"><b>[email protected]</a></b><p><br>
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