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?

Quesiton : 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: Significant risk device

Most relevent text from all around web: 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 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 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 ? Tue Sep 04 2018 · 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 non-significant risk device Fri Jan 27 2017 · 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 ? Tue Jun 26 2018 · Significant vs. Non-Significant Risk Devices. ... as well as the inherent risks of the device itself. ... A pacemaker that is a modification of a commercially available pacemaker poses SR because the use of any pacemaker presents a potential for serious harm...