Regulatory Affairs Certification (RAC) Practice Exam

What classification is given to a new pacemaker once it begins marketing on the same day its PMA is mailed to the FDA?

1. Approved

2. Adulterated

3. Class II Device

4. Not Marketed

The correct answer is: Adulterated

Once a new pacemaker begins marketing upon mailing its Premarket Approval (PMA) application to the FDA, the correct classification for the device is "Not Marketed." This is because the device has not yet received approval from the FDA to be sold or distributed. Marketing can only occur after the FDA has officially approved the device following their review of the submitted PMA, which assesses the safety and effectiveness of the device. The other classifications, such as 'Approved' or 'Class II Device,' do not apply in this context, as the device has not yet completed the necessary regulatory process to achieve those designations. It is important to understand these regulatory frameworks to accurately determine the status of medical devices in relation to FDA guidelines.