Question

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?Significant risk device T/F

Answer 1

Answer:True

Step-by-step explanation:

A significant risk device presents a potential for serious risk to the health, safety, or welfare of a subject.

It is classified as Significant risk device since it hopes that the new pacemaker will pose fewer risks to individuals when compared to the current commercially available product.