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Furthermore, many companies simply don't have the money to make all of the changes and meet all the other demands asked of them in order to bring their product up to meet FDA standards. And because there is much to share, this article is broken into three parts that are based on the three ideas Malaspina and Scearce impart. The question pertains to approval in Europe, Australia, Japan, Canada and how that relates to a US approval, and secondly, what type of 510(k) to prepare in the US.  Feel free to surf to my web blog;  http://www.longtailprosoftware.org/