The U.S. Food and Drug Administration (“FDA”) is seeking public input as it prepares its 2026 report on the risks and benefits to health associated with non-device software functions, including their impact on patient safety and related best practices. Stakeholders have only about one month to submit comments, which are due by August 13, 2026, under Docket No. FDA-2018-N-1910. FDA’s 2026 report will update the findings of its December 2024 Report on Risks and Benefits to Health of Non-Device Software Functions. In the 2024 report, FDA noted that available information generally reflected more benefits than risks to patient safety and health, but also acknowledged that adverse events may be underrepresented because adverse event reporting is not required for non-device software functions.
Background
Section 3060 of the 21st Century Cures Act (“Cures Act”), enacted on December 13, 2016, amended the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) to exclude certain categories of software functions from the definition of a medical device under section 201(h) of the FD&C Act. Under Section 520(o)(1)(A)-(E) of the FD&C Act as added by the Cures Act, certain medical software functions are not medical devices, including software functions that are intended (1) for administrative support of a health care facility; (2) for maintaining or encouraging a healthy lifestyle; (3) to serve as electronic patient records; (4) for transferring, storing, converting formats or displaying data; or (5) to provide limited clinical decision support.
FDA has since issued final guidance interpreting those exclusions, including Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act, issued on September 27, 2019, and Clinical Decision Support Software, issued on January 29, 2026, which reflect FDA’s current interpretations of the Cures Act’s medical software provisions.
Request for Input
The request invites practical input on how non-device software functions are used in health care settings, including their impact on patient safety, associated benefits and risks to health and best practices to promote safety, education and competency. Relevant examples may include user training, escalation pathways, change-management procedures, oversight of software recommendations, transparency of software outputs and monitoring for alert fatigue or overreliance.
The request may be particularly relevant to organizations that use limited clinical decision support functionality, electronic health record functionality, operational workflow tools, population health platforms, data-display tools or AI-enabled software functions that may fall outside FDA’s medical device definition.
Although these software functions are excluded from FDA’s medical device definition, FDA’s ongoing reporting process shows that the agency continues to monitor patient safety, public health, operational and governance implications. If the updated report identifies significant risks or negative public health impacts, FDA’s current guidance and policy approach could evolve.
How to Submit Comments
Stakeholders that develop, deploy, purchase or rely on non-device software functions should consider whether they have relevant operational experience, safety data, implementation lessons or governance practices that could help inform FDA’s 2026 report.
FDA requests input from all interested parties, including patients, consumers, health care providers, startup companies, health plans and other third-party payers, venture capital investors, information technology vendors, health information technology vendors, small business purchasers, employers and other stakeholders.
Comments may be submitted to the public docket at Regulations.gov using Docket No. FDA-2018-N-1910 and should be submitted by August 13, 2026, for consideration in the development of the report. Given the short comment window, organizations should promptly determine whether their experience with these tools may offer useful insight for FDA’s review.
For more information on medical devices, drugs or biologics, or for assistance with submitting comments, please contact:
- Carolina Wirth at (202) 780-2989 or cwirth@hallrender.com;
- Melissa Markey at (248) 740-7505 or mmarkey@hallrender.com; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot give legal advice outside of an attorney-client relationship.
