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FDA Seeks Input on Health Care Software Functions
FDA Requests Input on Certain Non-Device Software Functions and Impacts to Patient Safety
The U.S. Food and Drug Administration (FDA) requests input on patient safety associated with certain medical software functions excluded from the medical device definition. This input will help the FDA develop the 2026 report on the risks and benefits to health of non-device software functions, which include certain software functions intended for:
- Administrative support of health care facilities,
- Encouraging a healthy lifestyle,
- Serving as electronic patient records,
- Transferring, storing, converting formats, or display of data, and
- Providing limited clinical decision support.
Submitting Comments
Please submit comments under docket number FDA-2018-N-1910 at Regulations.gov by August 13, 2026.
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