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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
The Food and Drug Administration (FDA) recognizes the extensive variety of actual and potential functions of software applications (apps) and mobile apps, the rapid pace of innovation, and their potential benefits and risks to public health. The FDA is issuing this guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or "mobile apps") or on general-purpose computing platforms. Given the rapid expansion and broad applicability of software functions deployed on mobile or other general-purpose computing platforms, the FDA is issuing this guidance document to clarify the subset of software functions to which the FDA intends to apply its authority.
FDA refers to software functions that are device functions as "device software functions." Device software functions may include "Software as a Medical Device (SaMD)" and "Software in a Medical Device (SiMD)." Software functions that meet the definition of a device may be deployed on mobile platforms, other general-purpose computing platforms, or in the function or control of a hardware device. If a software function that meets the definition of a device is deployed on a mobile platform, it may be referred to as a "mobile medical app." The policies described in this guidance are independent of the platform on which they might run, are function-specific, and apply across platforms. Therefore, the policies described using terms such as "mobile medical apps," "mobile medical app manufacturers," "device software functions," and "device software function manufacturers" are not specific to whether the the function is deployed on a mobile platform or other general purpose-computing platform.
Many software functions are not medical devices (meaning such software functions do not meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)), and FDA does not regulate them as devices. Some software functions may meet the definition of a medical device, but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act).
Consistent with the FDA's existing oversight approach that considers functionality of the software rather than platform, the FDA intends to apply its regulatory oversight to only those software functions that are medical devices and whose functionality could pose a risk to a patient's safety if the device were to not function as intended.
FDA is issuing this guidance to provide clarity and predictability for software manufacturers. This document has been updated to be consistent with section 3060(a) of the 21st Century Cures Act, which amended section 520 of the FD&C Act, removing certain software functions from the definition of device in section 201(h) of the FD&C Act, and the guidance document entitled "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices," originally issued on February 9, 2015. Examples of mobile medical apps and software on the FDA web site (that were added after September 25, 2013) were incorporated into the appropriate appendices of this document for consistency.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-D-0530.