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jr377 replied to the topic Unapproved Device in the forum Introduction to Project Management 6 years, 8 months ago
May 2018 saw the signing of the “right to try” bill into federal law. It allows terminally ill patients to try experimental drugs, biologics, and devices that have completed phase I testing but hasn’t been FDA approved. Whether or not it is ethical is a different argument, but according to your question there are systems in place for “emergencies”.