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A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It is hoped that the new pacemaker will pose fewer risks to individuals when compared to the current commercially available product. How should this device be classified?

a. Significant risk device
b. non-significant risk device

Respuesta :

Answer:

A Significant risk device

Explanation:

A Significant risk device- it is referred to as a device that major function is to support human life. This includes all such devices used to diagnose, cure, treating disease to human health. An example of a significant device is a pacemaker, shunts used in heart, etc.

while on the other side nonsignificant devices include device like, eyes lens, its solution, dental scalers, etc