Regulatory Affairs Certification (RAC) Practice Exam

For a medical device involving drug, biologic, and device components, what regulatory action should a company take if the product has not been classified by the FDA?

1. Submit a 510(k) Application

2. File for Premarket Approval

3. A Request for Designation

4. Initiate a Clinical Trial

The correct answer is: A Request for Designation

In the case of a medical device that includes components related to a drug, biologic, and device, and has not yet been classified by the FDA, the appropriate regulatory action is to submit a Request for Designation (RFD). This request is utilized when a company seeks clarity on how the FDA would classify their product. The RFD allows the applicant to obtain an official determination regarding whether the product will be regulated as a drug, a device, a biologic, or a combination product. Submitting a Request for Designation helps to clarify the regulatory pathway to follow, which is essential for ensuring compliance with the relevant FDA regulations. This action is particularly important for combination products, as they may fall under the jurisdiction of multiple FDA centers, and understanding the classification is crucial for subsequent regulatory submissions such as a 510(k) application or Premarket Approval (PMA). By obtaining this designation, the company can better prepare for the next steps in the regulatory process, align their development plan accordingly, and reduce the risk of delays or regulatory issues down the line.