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What is a medical device? How does FDA classify medical devices? What are examples of medical devices? What is a humanitarian use device (HUD)? What is a humanitarian device exemption (HDE) application? What are the responsibilities of the IRBs regarding HDEs? Is informed consent required when treating/diagnosing a patient with a HUD? What statute and regulations apply to medcial device clinical investigations? What type of device studies do the IDE regulations cover? Are exempt studies ( i.e., exempt from the IDE regulation) subject to the requirements for informed consent and IRB review and approval? What regulation describes custom device? Can a physician use an unapproved device in an emergency? What if the situation is not an emergency? Can a patient with a serious illness or condition have access to an investigational device outside a study? |