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After consideration of the public comment we received and our review of the application, we agree with the applicant and have determined that the SCOUT MD TM Delivery System meets the criterion at 419.66(b)(4)

An untreated vitamin B12 deficiency can lead to neurological problems or pernicious anemia, which occurs when your body doesnt have enough B12 to produce the amount of red blood cells it needs ( Vitamin B12 shots are typically the most common way to prevent or treat a deficiency