Mobile apps that are intended to provide access to electronic “copies” (e.g., e-books, audio books) of medical textbooks or other reference materials with generic text search capabilities.As part of FDA’s ongoing effort to provide clarity to mobile app manufacturers this page includes all examples in Appendix A as well as updates with additional examples.
This list is not exhaustive it is only intended to provide clarity and assistance in identifying when a mobile app is not considered to be a medical device.Īppendix A in the guidance includes examples of mobile app functionalities not considered medical devices at the time the guidance was finalized. The FDA understands that there may be other unique and innovative mobile apps that may not be covered in this list that may also constitute healthcare related mobile apps. Because these mobile apps are not considered medical devices, FDA does not regulate them.
This list provides examples of mobile app functionalities to illustrate the types of mobile apps that could be used in a healthcare environment, in clinical care or patient management, but are not considered medical devices.
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