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.
Gottlieb announces pilot project for regulating digital health products
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