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Gottlieb announces pilot project for regulating digital health products

A soon-to-be-launched FDA pilot program would establish a third-party certification program allowing companies to market higher-risk digital health products with a streamlined premarket review and lower-risk products without a premarket review, Commissioner Scott Gottlieb wrote in a blog post. A guidance will also be issued by the FDA regarding its position on products that come with multiple software functions and fall outside the scope of the agency's regulations.

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