What is the Primary Mode of Action (PMOA) used for in combination products?

The Primary Mode of Action (PMOA) is critical in the regulation of combination products, as it primarily determines which FDA center will take the lead in the oversight of the product. The lead center is responsible for the product's premarket review and post-market regulation. For example, products that combine drug and device components may be evaluated by either the Center for Drug Evaluation and Research (CDER) or the Center for Devices and Radiological Health (CDRH), depending on the PMOA. Identifying the PMOA helps streamline the regulatory process by ensuring that the product is reviewed according to the expertise relevant to its primary function. By assigning the product to the appropriate FDA center based on its PMOA, the FDA can effectively manage the product's evaluation, approval, and compliance requirements. This process is foundational for ensuring that clients receive the correct guidance and regulatory pathway tailored to the specific characteristics of their combination product.