Final answer:
Any FDA class II device must be used under the supervision of a licensed physician. The FDA's CDRH regulates these devices for safety. Unscheduled or improper use without physician oversight can result in fines and endangers patient safety.
Step-by-step explanation:
The use of any FDA rated class II device without the documented supervision of a licensed physician may result in substantial fines. The FDA's Center for Devices and Radiological Health (CDRH) regulates the approval and oversight of medical devices to ensure their safety and efficacy. Examples of class II devices can include certain medical monitors, infusion pumps, and diagnostic ultrasound machines.
Drug abuse is defined as the use of a drug without the advice of a medical professional and for non-intended purposes. It is important for medical and non-medical devices that fall under the FDA's regulation to be used in accordance with legal and medical guidelines to avoid health risks and legal consequences.
Because class II medical devices can pose a moderate to high risk to the patient or user, it is critical that their use be supervised by a qualified healthcare provider. The use of these devices without such supervision can raise concerns about patient safety, leading to regulations that mandate fines or other penalties for unsupervised operation.