Non-Device Software Function Report

FDA has published “Report on Risks and Benefits to Health of Non-Device Software Functions — December 2022.” An agency notice says the report “highlights FDA’s Digital Center of Excellence findings on the five software functions excluded from the device definition by the 21st Century Cures Act.” The functions range from software that offers administrative support to a healthcare facility to software that helps patients keep a healthy lifestyle but is not specific to the treatment of a disease.

The notice says the report includes:

• findings on positive and negative impacts on patient safety and health benefits related to the use of the five software functions; and
• best practices related to implementation, training, and use that could promote safety, education, and competency.

The analysis includes information from experts outside FDA, peer-reviewed literature, adverse event report databases, and public input that the agency received through a Federal Register notice.