Section 3060(a) of the 21st Century Cures Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on December 13, 2016, removing certain software functions from the definition of device in section 201(h) of the FD&C Act. This guidance provides FDA's current thinking regarding the amended device definition and the resulting effect the amended definition has on FDA's guidances related to medical device software. The concepts detailed in this guidance are also reflected in the following guidance documents through Level 2 updates¹:

• General Wellness: Policy for Low Risk Devices
• Mobile Medical Applications
• Off-The-Shelf Software Use in Medical Devices
• Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

The following guidance document has been withdrawn, for the reasons described in Section IV.D:

• Guidance for the Submission of Premarket Notifications for Medical Image Management Devices

¹ A Level 2 guidance document sets forth "existing practices or minor changes in interpretation or policy. Level 2 guidance documents include all guidance documents that are not classified as Level 1" (21 CFR 10.115(c)(2)). Because this final guidance sets forth the initial interpretations of FDA's statutory and regulatory requirements relating to software functions, it is a Level 1 guidance (21 CFR 10.115(c)(1)). FDA is making Level 2 updates to the listed guidance documents to make them consistent with existing practices as expressed in this final guidance.