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Medical Devices / Regulatory Affairs

New FDA Guidance Narrows Agency Oversight of Digital Health Products

Dec. 18, 2017

The FDA published three new guidances on digital health products that limit the types of products the agency will regulate as medical devices.

A draft guidance on clinical decision support software describes the types of software that will no longer be classified as medical devices, putting them beyond the agency’s purview.

The Cures Act makes clear that certain digital health technologies—such as clinical administrative support software and mobile apps that are intended only for maintaining or encouraging a healthy lifestyle—generally fall outside the scope of FDA regulation, FDA Commissioner Scott Gottlieb told lawmakers in a December 7 hearing on Capitol Hill.

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