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or (2) for devices for which pass-through status will begin on or after January 1, 2020, as an alternative to the substantial clinical improvement criterion, the device is part of the FDA's Breakthrough Devices Program and has received FDA marketing authorization for the indication covered by the Breakthrough Device designation

This includes confirmed low serum vitamin B12 levels, pernicious anaemia, malabsorption states such as coeliac disease, inflammatory bowel disease, or post-gastric or bariatric surgery, unexplained anaemia, neuropathy or neurological symptoms consistent with vitamin B12 deficiency, a long-term vegan diet with symptoms or low levels, or failure of oral vitamin B12 supplementation

As with vegetarians, vegans can avoid this by consuming a dietary supplement or eating B 12 fortified food such as cereal, plant-based milks, and nutritional yeast as a regular part of their diet

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