On Dec. 8, 2017, the FDA released draft guidance, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.” This guidance discusses software functions in relation to the modified device definition in the 21st Century Cures Act and the criteria for interpreting if and how medical software will or will not be regulated. Note, however, that the 21st Century Cures Act allows regulation of devices excluded from regulation if a federal register notice finds it would be reasonably likely to have serious adverse health consequences. This guidance indicates that four other existing FDA software guidances will be modified to incorporate the policies indicated (related to application of these policies on a software function-specific basis and across platforms). That includes the Mobile Medical Applications, Off-the-Shelf Software (to remove Laboratory Information Management Systems (LIMS)), General Wellness, and Medical Device Data Systems guidances. This draft guidance contains many criteria and details regarding FDA’s legal authority (or lack thereof) to regulate medical software, and whether they will exercise enforcement discretion and not actively regulate. It includes related factors such as whether the software is certified by non-FDA HHS Office of the National Coordinator for Health Information Technology. The full guidance is at the link provided. FDA Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21 st Century Cures Act
