A company is developing an unapproved drug-device combination product. What application type should they submit?

When developing an unapproved drug-device combination product, the most appropriate application type to submit is the New Drug Application (NDA). This is because the primary component of the combination is a drug, and the NDA process is specifically designed for the approval of new drugs under the Federal Food, Drug, and Cosmetic (FD&C) Act.

In the case of a drug-device combination product, if the primary mode of action is attributed to the drug component, the FDA usually requires the submission of an NDA to ensure that the drug is safe and effective for its intended use. The NDA will include all necessary data from preclinical and clinical testing, manufacturing information, and labeling that aligns with drug approval processes.

While a Combination Product Application may seem relevant, it is a broader category used for products that fall under both the drug and device regulatory classifications, but the application itself doesn't exist as a standalone proposal. Instead, combination products usually leverage existing applications such as NDAs or PMAs (Premarket Approval applications) for devices, depending on which primary function is deemed most significant.

Thus, in the case of a company focusing on an unapproved drug-device combination where the drug aspect is central, submitting an NDA is the correct and standard procedure, fulfilling the regulatory requirements