Which of the following is NOT a role of the FDA Office of Combination Products?

The FDA Office of Combination Products is responsible for overseeing combination products, which are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. One of its key functions is to facilitate the review and approval processes for these products, ensuring they meet regulatory standards.

When considering the roles of the Office, one important aspect is that while it does guide the classification of combination products and enforces compliance with regulations, it does not engage in the actual development of new combination products. The development phase is primarily the responsibility of manufacturers and inventors. Instead, the Office focuses on ensuring that the products meet regulatory guidelines through their review and classification.

Providing guidance on product classification is a vital role, as it helps manufacturers understand how their products will be regulated, while enforcing compliance ensures that marketed products continue to meet the necessary safety and efficacy standards. Thus, while reviewing marketing applications for combination products is a critical function of the FDA, that specific task is executed by the respective review divisions, rather than the Office of Combination Products itself.

This understanding clarifies that the statement regarding the review of marketing applications is not a role of the Office of Combination Products, distinguishing it from the other functions that align more closely with the Office's responsibilities.