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Medical Devices / Regulatory Affairs

New FDA Guidance Narrows Agency Oversight of Digital Health Products

Dec. 13, 2017
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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A draft guidance on clinical decision support software describes the types of software that will no longer be classified as medical devices, putting them beyond the agency’s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 Dec. 7 hearing on Capitol Hill.

Software that will continue to fall under the FDA umbrella includes products whose primary function is processing in vitro diagnostic device signals, medical images and patterns acquired from processors.

In a separate draft guidance, the FDA proposed changes to existing guidance documents to better align them with the Cures Act’s provisions. The guidance would establish that mobile apps aimed at improving lifestyle health generally, such as Fitbit and other step trackers, are not subject to FDA regulations.

The agency also issued a final guidance outlining steps required to generate clinical evidence of effectiveness and safety of software as a medical device, developed in collaboration with the International Medical Device Regulators Forum.

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