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After careful consideration of the comments, we are finalizing our proposal to group skin substitutes (other than those approved via BLA under section 351 of the PHS Act) into three FDA categories, PMA, 510(k), and 361 HCT/Ps, for purposes of developing payment rates in future notice and comment rulemaking, as proposed

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However, increasing oral supplement doses (within safe limits) while awaiting medical review is generally considered safe, as B12 has very low toxicity and excess is excreted through the kidneys