Abstract
Designing the biological safety program is our opportunity to define risk control. However, if our biological safety program is solely based on testing, it is then solely reactive. I test and discover that my product is likely biocompatible or has some issues that could compromise biological safety. I have a program based on pass or fail. I have wasted time and money only to find out that I have a problem. This is not the best approach. Biological safety is a control program. Therefore it is a feedback loop mechanism. The control of adverse events is based on intended use, the materials of construction, and the manufacturing materials and processes. Biological safety must be designed into the product. Equal emphasis must be placed on the materials and the process relative to intended use.
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