GPSV Guidance draft- CDRH Presentation on comments

The attached are slides from a presentation given by Stewart Crumpler of FDA CDRH regarding comments received on the draft “General Principles of Software Validation Guidance”. This presentation was given in July 1999 at the Biofocus conference. The intent is to resolve comments and issue a final guidance in early 2001.

Stewart Crumpler Presentation at BioFocus99

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FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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