This guide was put together as an additional resource, aside from the UPKs, including each FDA Program group, to address areas within FDA that now require decision making based upon the product you have as to what will be required by CBP/FDA. Each program group will have its own requirements, so the sections will look a bit different from each other.
With these new ACE requirements for FDA, some information is mandatory, some is conditional and some is optional. We will focus on the mandatory and conditional elements that are new/different than before. This guide will not contain system specific information, as this is available in the UPKs.