Regulatory Affairs Certification (RAC) Practice Exam

The requirement for identifying the control number for each unit, lot, or batch of finished devices is particularly important for medical devices that are implantable, such as pacemakers. Implantable devices must adhere to strict tracking and monitoring regulations due to their impact on patient safety and health outcomes. The control number enables manufacturers and regulatory bodies to trace and recall specific devices when necessary, ensuring that any adverse events or malfunctions can be promptly addressed.

In contrast, while surgical gloves, X-ray machines, and syringes are also regulated medical devices, they do not usually require the same level of detailed tracking at the unit or lot level as implantable devices. Surgical gloves, for instance, are generally considered single-use and do not require tracking to the same extent. X-ray machines are larger systems that may have different regulatory requirements, focusing more on equipment safety and performance rather than tracking individual units. Syringes, while important, also do not have the same implantable status that necessitates detailed control number tracking.

Therefore, the correct choice is pacemakers, as they epitomize the necessity for thorough identification procedures to maintain patient safety and regulatory compliance.