How much time to you spend searching FDA’s website? Looking for predicates, collecting adverse event reports from the MAUDE database, searching for guidance documents, etc. I’m sure I don’t need to dig into the details, you have felt this pain too if you have spent any appreciable amount of time on the www.fda.gov. Albeit a great source of information, it is a complex web of blue pages, and it takes a very large amount of time (and money!) to find the information you are looking for.