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The FDA definition of devices encompasses software intended by the manufacturer to be used, alone or in combination for the specific medical purpose of diagnosis, prevention monitoring treatment or alleviation of disease and does not achieve its primary intended action by pharmacological, immunological or metabolic means

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In the CY 2023 PFS final rule (87 FR 69961), CMS added the beneficiary information follow up communication requirement under 425.312(a)(2)(v), which requires an additional follow up with a beneficiary who has received the beneficiary notification