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US FDA warns against design complacency:

This article was originally published in Clinica

Executive Summary

The FDA has warned US companies not to be complacent about design control requirements despite having a one-year grace before they become fully implemented in June 1998. Speaking at an FDA/Food and Drug Law Institute conference last week, FDA quality system expert, Kim Trautman, told companies they needed to make good use of this grace period to "fine-tune their design control systems". Last week the FDA issued a final guidance document on its design control rules.

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