08/09/2022

The US Food and Drug Administration (FDA) is requesting input from stakeholders and patients on patient safety for medical software functions that are not defined as medical devices by the 21st Century Cures Act (“Cures Act”) of 2016. Some examples of these are healthy lifestyle apps, electronic medical records, and systems that display lab results. Also see the guidance, “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.” Because software is rapidly changing, the Cures Act requires risks and benefits of the excluded medical software functions to be reevaluated every two years. The last two reports are available here:

The requested input is related to software functions that are not medical device, but understanding instances that software is a medical device is helpful for distinguishing the difference. Definitions related to software as medical device are:

Software as a Medical Device (SaMD): “Software that meets the definition of a device in section 201(h) of the FD&C Act and is intended to be used for one or more medical purposes without being part of a hardware device.”
Software in a Medical Device (SiMD): “Software that meets the definition of a device in section 201(h) of the FD&C Act, and is used to control a hardware device or is necessary for a hardware device to achieve its intended use. Typically, SiMD is embedded within or is part of a hardware device.”

Do you use medical software functions that are not medical device, or that are SaMD/SiMD?

Comment now through August 15th HERE.