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What's the Difference Between a Device and an Approved Product?
As long as it doesn't change the essential critical functionin of the device, then you don't have to go through their clearance process or approval process. When you cross the line too actually, this is a substantially new change in the product. And so i think in many instances to what beau was talking about, there are some challenges around whether or not it changes a critical function. With softworg, it's a constant evolving beast. It's really important to be able to do those changes. Otherwise all our softwor products are going to be on blackberries, and that’s not good. The f d a has released a new program called precert, which...