In December 2018 the FDA released a report that focused on the health impacts of non-device medical software, in addition to best practices.The report was issued in accordance with the 21st Century Cures Act: legislation initially enacted in 2016 that requires the Secretary of Health and Human Services (HHS) to publish a report every two years that examines the health risks and benefits associated with non-device medical software. The report itself is only necessary in light of a previous amendment under the Cures Act, which excludes certain software functions from the technical definition of a medical device. Understanding the discrepancy between non-device medical software and medical devices can provide useful insight into the complex field of medical technology oversight.
How does the FDA classify a medical device?
The Federal Food, Drug, and Cosmetic Act (FD&C) originally defined a medical device as “ an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:”
- Intended for the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals.
- Intended to affect the function or structure of the body of humans and animals without the primary use of chemical actions within or on the user.
This broadly defined specification permits a wide range of medical technology to fall under FDA regulation, including various forms of medical software.
How does the FDA define non-device medical software?
While the FDA’s medical device classification does include certain types of medical software, the agency distinguishes between device and non-device medical software. Non-device medical software can be categorized as software which:
- Provides administrative support to a health care facility.
- Serves to maintain or encourage a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition.
- Primarily functions to house electronic patient records and is not intended to interpret or analyze patient records
- Is used to transfer, store, convert, or display data
- Provides certain types of clinical decision support to a health care provider without interpreting or analyzing a clinical test or other device data
The Purpose of Distinction
Each year, thousands of medical device companies, entrepreneurs, and researchers send the FDA applications for premarket approval—which requires demonstration of a device’s safety and efficiency. Yet non-device medical software remain exempt from this process, due to their unique role within health care. While arguably as significant as other medical devices, this form of medical technology is deemed complementary to direct care.
While the FDA does not directly regulate non-device medical software, the agency regularly reviews the use and effectiveness of such technology. As noted in the agency’s report, the FDA partners with the Office of the National Coordinator for Health Information Technology (ONC) to regularly publish reports, provide advisements, and coordinate efforts to advance health information technology.