Question

Medical devices are grouped into 3 categories according to Medical Device Amendment of 1976. Which class of devices is most regulated?

A. I class.
B. II class.
C. III class.
D. IV class.

Answer 1

The most regulated class of medical devices according to the Medical Device Amendment of 1976 is Class III, which includes high-risk devices like implantable pacemakers and heart valves.

Step-by-step explanation:

The class of medical devices that is most regulated according to the Medical Device Amendment of 1976 is Class III. These devices are considered to have the highest risk to patients and require the most rigorous regulatory controls to provide reasonable assurance of their safety and effectiveness. Examples of Class III devices include implantable pacemakers and heart valves. In contrast, Class I devices are the least regulated, and Class II devices have more regulatory controls than Class I but less than Class III. There is no Class IV category in the FDA's classification system.