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The 21st Century Cures Act (12/13/2016) amended the definition of device in
the Food, Drug and Cosmetic Act to exclude certain software functions,
including some described in this guidance document.
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Guidance for form submission is a set of instructions provided to help individuals or entities complete and file a specific form.
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The purpose of guidance for form submission is to assist individuals or entities in correctly completing and filing the specific form.
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