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Specifically, we are finalizing that DMHT devices under this payment policy must be cleared under section 510(k) of the FD&C Act or granted De Novo authorization by FDA and in each case must be classified under 21 CFR 882.5801 for mental or behavioral health treatment

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J ASEAN Fed Endocr Soc 35(2):163168 Gao L et al (2023) The effects of daily dose and treatment duration of metformin on the prevalence of vitamin B12 deficiency and peripheral neuropathy in Chinese patients with type 2 diabetes mellitus: a multicenter cross-sectional study

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