If a company developing a drug-device combination product is uncertain about its marketing application submission, what should they first submit?

When a company is developing a drug-device combination product and is unsure about how to proceed with its marketing application submission, the most appropriate first step is to submit a Request for Designation to the Office of Combination Products (OCP). This request helps clarify how the FDA will regulate the product in question, determining whether it will be classified as a drug, a device, or a combination of both.

By submitting this request, the company seeks guidance on the regulatory pathway, which is essential for ensuring compliance with the appropriate regulations. The OCP will assess the product’s intended use, characteristics, and any relevant details to make this determination. This process assists in aligning the company's development plans with regulatory expectations and helps avoid unnecessary delays in the marketing application process.

While other options may have their roles later in the development process, they do not serve as the initial means of clarification regarding regulatory status and submission requirements.