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  • aja38 replied to the topic Unapproved Device in the forum Introduction to Project Management 6 years, 11 months ago

    I don’t agree in using unapproved devices because it is a Hail Mary attempt to treat someone. It could cure but there is a high chance that it could cause more pain. Physicians can enlist patients in clinical trials that are testing FDA unapproved medical device/drug. However, before being part of the trial the physician must information all warning and side affect that the patient will encounter during the trial. Physicians must also run pre-examination and background studies because there are specific requirements that patient must being to be consider in the study. So to summarize I don’t agree on using unapproved medical device but they can be used by physicians if the patient is approved for the study.