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Reports on Non-Device Software Functions

Update: July 14, 2026

FDA Requests Input on Certain Non-Device Software Functions and Impacts to Patient Safety  

The FDA requests input on patient safety, including best practices to promote patient safety, education, and competency, associated with medical software functions that are excluded from the medical device definition by the 21st Century Cures Act. 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 displaying data, and 
  • Providing limited clinical decision support.

Please submit comments under docket number FDA-2018-N-1910 at www.regulations.gov by August 13, 2026. 

These reports are published every two years and examine information on any risks and benefits to health associated with non-device software functions described in section 520(o)(1)(A)-(E) of the FD&C Act and provide findings on their impact on patient safety, including best practices.

Additional Reports

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