Regulatory Affairs Certification (RAC) Practice Exam

A company developing a drug-device combination product should initially determine its primary mode of action (PMOA) through which entity?

1. Office of Drug Evaluation

2. Office of Combination Products

3. Office of Biostatistics

4. Center for Drug Evaluation

The correct answer is: Office of Combination Products

Determining the primary mode of action (PMOA) of a drug-device combination product is a critical step in the regulatory approval process, as it influences the regulatory pathway the product will follow. The Office of Combination Products plays a central role in this determination. This office is specifically tasked with the oversight and coordination of products that combine two or more regulatory classifications, such as a drug and a device. The Office of Combination Products evaluates the product to establish which component—drug or device—has the primary intended therapeutic effect. This PMOA determination is crucial because it affects which FDA center will have jurisdiction over the product's regulation, influencing the subsequent pre-market review process. By identifying the PMOA early in development, companies can better align their submissions with the relevant regulatory requirements and streamline their interactions with the FDA. Other entities such as the Office of Drug Evaluation focus primarily on drugs, and the Center for Drug Evaluation is more broad and encompasses various aspects of drug regulation. The Office of Biostatistics plays an important role in statistical analysis but does not have the jurisdiction over PMOA determination for combination products. Thus, the Office of Combination Products is uniquely positioned to assess and confirm the PMOA for drug-device combination products.