Regulatory Affairs Certification (RAC) 2025 – 400 Free Practice Questions to Pass the Exam

When confronted with uncertainty regarding the appropriate submission pathway for a marketing application for an unapproved drug-device combination product, the most logical and beneficial step is to submit a Request for Designation. This request serves as a formal inquiry to the regulatory authority, typically the FDA in the United States, to determine the classification of the product.

The Request for Designation is particularly advantageous because it allows the company to clarify whether the product is regulated primarily as a drug, a device, or both. This clarification is crucial for understanding the specific regulatory requirements and the appropriate submission process. It ensures that the company complies with the correct regulations from the outset, thereby potentially streamlining the approval process.

Submitting a Request for Pre-Submission or a New Drug Application, for example, may not provide the necessary guidance on classification and could lead to misalignment with regulatory expectations. Similarly, a 510(k) submission is specific to devices and would not be appropriate if the product is primarily a drug. Therefore, initiating contact with the regulatory body through a Request for Designation is the strategic first step in navigating the complexities of drug-device combination product submissions.