Which of the following subsystems is NOT required by the FDA for a Quality System?

The correct answer is that "Test and control article characterization" is not a mandated subsystem by the FDA for a Quality System. The FDA requires medical device manufacturers to establish and maintain a quality management system in accordance with regulations. Key subsystems, such as production and process controls, packaging and labeling controls, and facility and equipment controls, are essential elements within this framework as they directly contribute to ensuring product quality and regulatory compliance.

Production and process controls are critical as they relate directly to how devices are manufactured and the quality assurance processes during production. Packaging and labeling controls are equally vital, ensuring that products are packaged correctly and labeled per regulatory requirements, which helps to maintain product integrity and safety. Facility and equipment controls ensure that the environments in which products are manufactured and tested meet specific standards to avoid contamination and ensure proper functioning.

In contrast, while "Test and control article characterization" is important for research and development, it is not explicitly mandated within the FDA’s quality system requirements for all medical devices. This subsystem primarily relates to the characterization of investigational products and is more relevant in the context of clinical trials or specific product development phases rather than as an ongoing requirement for quality control in production or manufacturing environments.