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Olegator [25]
3 years ago
10

A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It is hoped that the new pacemaker wil

l 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
Business
1 answer:
Dafna1 [17]3 years ago
8 0

This device has been classified as Significant risk device.

a. Significant risk device

<u>Explanation:</u>

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.

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3 0
3 years ago
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8 0
3 years ago
Read 2 more answers
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