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    Expanded Access Programs for Medical Devices

    Expanded access, also referred to as compassionate use, is a vital pathway for patients with life-threatening diseases to gain early access to unapproved investigational medical devices. This article summarizes expanded access programs for medical devices in the US, Europe, Japan, Canada and Australia. Background The average time from medical device concept to marketing approval has been reported as three to seven years. 1 This long-time lag is problematic for patients...