Obstacles a Principal Investigator Health Professional May Need to Overcome in a Pivotal Investigational Device Exemption Clinical Trial of a Class 2 Medical Instrument at a Major Medical Center /

There are major differences between large-scale clinical trials for medications and medical devices, especially low-risk medical devices (Class 2) intended primarily to improve hospital efficacy and patient comfort. Unlike the affirmative studies required for medications, and the step-by-step near-c...

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