FDA open docket now available for feedback on benefits and risks of software that are not devices

May 30, 2018

Starting May 29, you can submit your comments on risks and benefits to health associated with software functions excluded from the device definition by the Cures Act. The docket closes on June 28, 2018. The FDA will incorporate public input into a report the agency is developing, which will be published as required by Congress, that summarizes the impact of such software functions on patient safety, including best practices to promote safety, education, and competency related to such functions.

As part of the Cures Act, the FDA, in consultation with agencies and offices of the Department of Health and Human Services (HHS) involved in health information technology, is examining information on risks and benefits to health associated with software functions excluded from the device definition by the Cures Act.

Continuously providing clarity for manufacturers, FDA staff, and other stakeholders on the medical software provisions of the 21st Century Cures Act is part of the FDA’s long-term Digital Health Innovation Action Plan.

If you have questions about how the 21st Century Cures Act affects your products, or if you have comments on how the FDA should regulate medical software, please email [email protected].

Submit your comments here

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