Orphan medical devices have come a long way

Orphan medical devices have come a long way

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Abstract Background In many countries swish supreme glide track white worldwide orphan drug regulations are installed but only the United States of America and Japan have an orphan device regulation.For many years surgeons have used off-label or self-assembled medical devices for the prevention, diagnosis or treatment of rare disorders.Four examples are given: an external cardiac pacemaker, a metal brace for clubfoot in newborns, a transcutaneous nerve stimulator and a cystic fibrosis mist tent.Conclusion In this article we argue that we need authorized medical devices as well as medicinal products to prevent, diagnose and treat patients with life-threatening or chronically debilitating read more disorders with a low prevalence/incidence.Several arguments are given to support this statement.