Regulatory Affairs Certification (RAC) 2025 – 400 Free Practice Questions to Pass the Exam

A device is considered adulterated under FDA regulations primarily when it is manufactured in conditions that are unsanitary, which can compromise the safety and effectiveness of the device. The standard of manufacturing practices set forth by the FDA requires that devices be produced in environments that are clean and controlled to prevent contamination. If a device is made under unsanitary conditions, it may pose risks to patients, such as infection or malfunction, which justifies its classification as adulterated.

In contrast, the other options do not meet the criteria for adulteration as defined by the FDA. A device being approved but not marketed does not affect its quality or safety; it simply reflects its market status. The pricing of a device, while potentially a concern from an economic viewpoint, does not relate to its adulteration; a device may be expensive yet still comply with safety and manufacturing standards. Additionally, misleading labeling pertains more to misbranding rather than adulteration, focusing on how the device is presented rather than the conditions under which it was produced.