Abstract Background In many countries 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. https://www.soiebiologique.com/quick-sale-Axol-Friends-Mel-Axol-the-Axolotl-Black-Purple-special-save/