Which of the following subsystems is NOT required by FDA in order to implement and maintain a Quality System?

The correct choice is based on how the FDA delineates the components necessary for a Quality System under the Quality System Regulation (QSR). The QSR emphasizes that certain subsystems are essential for maintaining quality in manufacturing medical devices.

Production and process controls are crucial because they ensure that devices are manufactured consistently and according to established specifications. This is vital for maintaining the integrity and safety of medical devices. Similarly, packaging and labeling controls are indispensable as they directly affect the safety and effectiveness of the product, ensuring that users receive the correct information and that devices are appropriately contained to prevent damage.

Facility and equipment controls also play a significant role, as proper maintenance of facilities and equipment is essential to produce devices that meet required quality standards. Each of these subsystems directly contributes to the effectiveness of the Quality System by ensuring compliance with regulatory standards.

However, test and control article characterization, while important for certain types of quality assessments and development processes, is not explicitly required under the FDA's QSR for the implementation and maintenance of a Quality System. This subsystem is more relevant to specific testing phases rather than a comprehensive quality management structure. Thus, it is not mandated as a necessary component to maintain overall quality compliance for the manufacturing and production environment as outlined by the FDA.