The FDA requests your input for the 21st Century Cures Act Report – Section 3060

The FDA requests your input for the 21st Century Cures Act Report – Section 3060(b)

The U.S. Food and Drug Administration (FDA) is requesting your input on patient safety, including best practices to promote patient safety, education, and competency, associated with the medical software functions excluded from the device definition by the Cures Act for inclusion in a report to the public. Software functions excluded from the device definition include: administrative support for health care facilities encouragement of healthy lifestyles electronic patient records transferring, storing converting formats, or displaying data providing limited clinical decision support

View the Request for Input The Cures Act, signed into law on December 13, 2016, is designed to help accelerate medical product development and bring innovation and advances to patients who need them faster and more efficiently. On September 27, 2019, the FDA issued the guidance Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act with the most current interpretations of the medical software provisions in the Cures Act. Your input must be submitted by July 30, 2020 to help the FDA develop a report that includes your feedback on the risks and health benefits of the software functions excluded from the device definition by the Cures Act. Submit Comments Questions? If you have questions, contact the Division of Industry and Consumer Education.