[Answer] 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? Conflicts of Interest in Research Involving Human…

Answer: Significant risk device Research and HIPAA Privacy Protections
A sponsor proposes research to evaluate reengineering a commercially available pacemaker. It is hoped that the new pacemaker will pose fewer risks to individ…

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