If you’re developing a medical device that’s substantially equivalent to an existing device, then the FDA classification process can seem straightforward. Simply head over to the classification database on the CDRH website, enter the relevant information about your product, hit the search button, and viola! You can quickly determine whether your device fits into the Class I, II, or III category. At least, that’s what most people think. Reality, however, is far more complicated, and there are exceptions to every rule. The best regulatory strategies take advantage of the exceptions – not just the rules.