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?

The reengineered pacemaker should be classified as a Class III medical device. Class III devices are considered high-risk because they support or sustain human life, are implanted, or present a potential unreasonable risk of illness or injury. Given that the pacemaker is a critical life-sustaining device and the new version involves significant changes aimed at reducing risks, it requires the highest level of regulatory control to ensure safety and effectiveness. This classification mandates rigorous evaluation, including clinical trials and premarket approval processes, before it can be marketed