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Because obviously you can appreciate that if the device is designed only for a physician to use, the design might be a little different or in some cases significantly different than the if it's going to be used by a lay user or a patient, and then some additional kind of miscellaneous topics like for example, the usability testing, how that's different, the labeling requirements, cleaning disinfection, universal device identifiers, UDI

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Patients should discuss any allergies or medical conditions with their healthcare provider before starting MIC B12 injections