Which statement is TRUE regarding an adulterated medical device?

An adulterated medical device is defined by the Federal Food, Drug, and Cosmetic Act (FDCA) as one that fails to comply with the Quality System Regulations (QSR), which set the standards for device manufacturing. This includes any violations of regulations related to manufacturing practices, quality assurance processes, and controls that ensure the device's safety, effectiveness, and performance.

When a device does not comply with any paragraph of the QSR, it presents a risk to patients and users, leading to its classification as adulterated. The focus here is on compliance with established standards during the manufacturing process, which is critical for ensuring the overall integrity of the medical device.

The other choices relate to aspects that can contribute to the classification of a device as misbranded or may indicate issues with its marketing and labeling rather than its manufacturing quality. For example, misleading information might pertain to advertising practices rather than the physical characteristics or safety of the device itself, while a lack of a cleared 510(k) may relate to marketing authorization issues rather than direct compliance with manufacturing quality standards.