What is an example of a Class I FDA approval device?

Class I devices are those considered to have the lowest risk to patients and are typically subject to the least regulatory control. They generally do not require premarket approval, and the manufacturers are required to follow good manufacturing practices.

A bandage is a prime example of a Class I device. This is because bandages are simple, non-invasive products that are used to cover minor wounds and do not pose a significant risk to the wearer. Their regulation focuses primarily on ensuring that they are manufactured consistently and safely, rather than requiring extensive clinical testing or premarket review.

In contrast, an X-ray machine, pacemaker, and breast implant are classified as Class II or Class III devices due to their increased complexity and higher potential risks to patients, necessitating more rigorous evaluation before they can be marketed. Thus, the correct answer, the bandage, exemplifies the basic characteristics of Class I devices.