The FDA’s Digital Health Center of Excellence findings on the five software functions excluded from the device definition by the 21st Century Cures Act.
- eastanglian
- 2024年12月8日
- 読了時間: 1分
On Thursday, December 06, 2024, the FDA published the Report on Risks and Benefits to Health of Non-Device Software Functions – December 2024. This report highlights the FDA’s Digital Health Center of Excellence findings on the five software functions excluded from the device definition by the 21st Century Cures Act. These software functions range from software that offers administrative support to a health care facility to software that helps patients maintain a healthy lifestyle but is unrelated to the prevention or treatment of a disease. The report analysis includes information from experts external to the FDA, peer-reviewed literature, adverse event report databases, and public input that the FDA received through a public docket.
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