Which item is an example of a Class I medical device?

Which item is an example of a Class I medical device?

• A. Magnetic resonance imaging machine
• B. Implantable cardioverter-defibrillator
• C. Insulin pump
• D. Dental floss

Answer: (D)

Class I devices are the lowest-risk category and are regulated mainly by general controls. They are typically simple, noninvasive items that pose minimal potential for harm and often do not require extensive premarket data. Dental floss fits this description as a straightforward tool used for oral hygiene with very low risk. The other items involve higher risk: an MRI machine is a complex diagnostic tool with potential safety considerations; an implantable cardioverter-defibrillator is an implanted device that directly affects heart rhythm and patient safety; and an insulin pump delivers medication with dosing and mechanical risks. Thus, dental floss best represents a Class I medical device.

Class I devices are the lowest-risk category and are regulated mainly by general controls. They are typically simple, noninvasive items that pose minimal potential for harm and often do not require extensive premarket data. Dental floss fits this description as a straightforward tool used for oral hygiene with very low risk. The other items involve higher risk: an MRI machine is a complex diagnostic tool with potential safety considerations; an implantable cardioverter-defibrillator is an implanted device that directly affects heart rhythm and patient safety; and an insulin pump delivers medication with dosing and mechanical risks. Thus, dental floss best represents a Class I medical device.