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FDA Digital Health Policy Navigator

The Digital Health Policy Navigator is a tool intended to help product developers understand whether a software function is potentially subject to or the focus of the FDA's regulatory oversight as a device, and if so, the considerations that may assist in determining the applicable FDA-specific legal and regulatory requirements and recommendations. The Navigator provides an interactive overview of digital health policies that may apply to your product's software functions and accounts for changes to existing medical software policies resulting from section 3060 of the 21st Century Cures Act.


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