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?

Answer 1

Significant risk device

Explanation:

Significant risk devices are those devices which might involve the implants, devices that support or assist or sustain the human life. And these devices are substantially vital in treating disease, diagnosing, mitigating and curing ir prevent the impairment to the human life.

So, in this case, it is stated or hoped that the new pacemaker will have fewer risks to the individuals when it is compared to the present available product. Therefore, this device will be recognised as the significant risk device.