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FDA finalizes plans to deregulate MDDS health software

Article Excerpt: Last June in a draft guidance document, the FDA proposed to further de-regulate a specific type of health software, which included a number of mobile medical apps and telehealth platforms, from FDA-registered Class 1 devices to an unregulated status. Last week the FDA moved to finalize that guidance, building on a spate of recent guidances that both make clear where regulatory lines for health software already exist and move some healthtech categories into unregulated territory.

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Article Source: mobihealthnews