Specifications include, but are not limited to: • Recommended regulatory classification, device class, product code/predicate devices (if applicable), and submission type • Determination of predicates to the invention or other similar products that have been cleared • Review the need for clinical trials, either to secure initial clearances or approvals, as compared to similar products, and how large and long those comparable trials took to complete • Identify the breadth or limitations for an initial proposed intended use and potential indications for use labeling claims that might secure earliest commercialization • Impact of proposed claims on regulatory pathway and timing • Timeline to marketing authorization, inclusive of any required clinical trials, and associated FDA fees