Regulatory Affairs Certification (RAC) Practice Exam 2026 - Free RAC Practice Questions and Study Guide

For a new pacemaker to be classified as marketed, it must have received FDA approval and completed the necessary regulatory processes. Mailing a Premarket Approval (PMA) application to the FDA does not mean that the device is authorized for marketing—approval has not yet been granted. Until the FDA reviews and approves the PMA, the device is not allowed to be marketed.

The classification as "Not Marketed" emphasizes that the device cannot legally be sold or distributed until it receives formal approval from the FDA. This ensures that devices are safe and effective prior to being available to healthcare providers and patients. Therefore, even if a company sends a PMA application, marketing status will remain "Not Marketed" until the FDA has completed its review and granted the approval.