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?
a. Significant risk deviceb. non-significant risk device

Answer 1

This device has been classified as Significant risk device.

a. Significant risk device

Explanation:

Significant risk devices may incorporate inserts, devices that help or continue human life and device that are considered significant in diagnosing, restoring, alleviating or treating a malady or in forestalling impedance to human wellbeing. It permits an investigational device to be utilized so as to gather wellbeing and adequacy information required to help a premarket endorsement accommodation for Food and Drug. So this device has been classified as a Significant risk device.