FDA Asks Input on Non-Device Software Functions, Impacts
FDA is asking for input on certain non-device software functions and their impacts on patient safety. A Digital Health Reports online notice says the agency is requesting input on patient safety, including best practices to promote patient safety, education, and competence, associated with medical software functions that are excluded from the medical device definition by the 21st Century Cures Act.
FDA says the input will help it to develop the 2024 report on the risks and benefits to health of non-device software functions, which include certain software functions intended for:
- administrative support of healthcare facilities;
- encouraging a healthy lifestyle;
- serving as electronic patient records;
- transferring, storing, converting formats, or displaying data; and
- providing limited clinical decision support.
The notice includes instructions for submitting input by 7/18.