Rob Packard It depends upon the jurisdiction within the FDA. If the primary function of the product is a drug, then the drug division has jurisdiction and the company submits an NDA with a device section added to the manufacturing section typically. However, if the product is primarily a device with a drug component (i.e., drug coating), then CDRH has jurisdiction. Typically this type of product will not have a predicate that is Class II. If there is no predicate, then you have two options; 1) a PMA with a drug component to the submission, or 2) a De Novo application with a drug component. If there is a predicate that is Class II, then you would submit a traditional 510(k). It is likely that there would be a special controls guidance indicating additional testing to provide for a 510(k) with a drug component. If you still have doubts, you would contact the Office Combination Products and ask for a pre-sub meeting. Combination products are a turf war and it is important to have juridiction well-defined in advance. The most common route is a PMA with a drug component to the submission.

G M Butcher Read the FDA website http://www.fda.gov/CombinationProducts/default.htm
If there is no official or draft guide, contact the Combo Products Office at FDA.
Your company is a consulting firm - strange question?