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FDA to assess impact of medical device definition under Cures Act

The Food and Drug Administration is seeking stakeholder feedback on the benefits and risks to health associated with the software functions excluded from the medical device definition by the 21st Century Cures Act.

Section 3060 of the Cures Act compels the FDA to exclude certain software functionalities from the definition, effectively prohibiting the agency from regulating that software as a device.

The FDA announced on Tuesday that it is specifically requesting input on the impact of the software functions that are intended for administrative support of a healthcare facility; maintaining or encouraging a healthy lifestyle; serving as electronic patient records; transferring, storing, converting formats or displaying data; or providing limited clinical decision support.

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