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20 June, 08:16

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?

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  1. 20 June, 11:26
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    Because the pacemaker is a very high-risk device, but has the opportunity to pose fewer risks, it should be classified as a significant risk device.
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