FDA Guidance: Mobile Medical Apps, 2/15
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In February, 2015, the FDA issued this version of “Guidance for Industry and FDA Staff, Mobile Medical Applications.” This document provides information to mobile app manufacturers, distributors, and others about how the FDA intends to apply its regulatory authority to software applications intended for use on mobile platforms.
“Mobile Apps” are defined as software applications that can be run on mobile platforms (i.e., hand-held commercial off-the-shelf computing platforms, with or without wireless connectivity), or a web-based software application that is tailored to a mobile platform, but is executed on a server.
Sections of this Guidance include:
- III.C. Definition of a Mobile Medical App
- III.E. Definition of a Mobile Medical App Manufacturer
- VI and Appendix E. Regulatory requirements for Mobile Medical App Manufacturers
- Appendix A. Examples of Apps that are not Medical Devices
- Appendix B. Examples of Apps where the FDA will apply enforcement discretion
- Appendix C. Examples of Apps that are Medical Devices
- Appendix F. Frequently Asked Questions
The Mobile Medical App guidance was updated to be consistent with Guidance for Industry and FDA Staff – Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices which was issued on the same day.
| Issuing Body | FDA Guidance Documents |
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