Investigational Software Guidance

Version Date: May 9, 2013

Under FDA regulations, software that meets the definition of a medical device is regulated in the same way as other medical devices.  The IRB must make regulatory determinations regarding the use of medical device software in research. This guidance gives an overview of the information that study teams should include in protocol documents and ARROW applications for studies involving investigational software, to enable the Health Sciences IRB to evaluate the regulatory status of the software.

When is software considered an FDA-regulated device?
The FDA considers software a medical device if it is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease (i.e. it meets the legal definition of a medical device in section 201(h) of the Federal Food Drug and Cosmetic Act).  Software intended for these purposes is considered a medical device whether it is “standalone” software meant for use on a general-purpose computer/other device (such as an application for a handheld device), or it is a component of or accessory to another medical device (such as a magnetic resonance diagnostic device or computed tomography x-ray system).  

When is software considered investigational?
As with any other FDA-regulated device, software is considered investigational when it is the object of research involving one or more subjects to determine its safety or effectiveness for a specific indication, which includes for example, software tested in a study which is newly developed or modified from existing software, or that is being studied for an indication different from its labeling.

Which device studies are subject to FDA investigation device exemption (IDE) regulations?
An IDE must be obtained from the FDA before beginning any study using investigational software except as follows:

What information about investigational software should be included in the IRB protocol and application?  

How should the ARROW application be completed to identify research involving investigational software?

Who determines the risk level of an investigational software (or other device) study when an IDE is not sought?
The device sponsor makes an initial significant risk (SR) or non-significant risk (NSR) determination.  Unless the FDA has previously made an SR or NSR determination applicable to the study, the IRB must decide if it agrees with the sponsor’s determination.  The IRB’s determination is based on the risks of the device as it will be used on the study, and the nature of the harm that may result from the use of the device and/or from additional procedures associated with the device study.  (Note that an SR / NSR determination is distinct from a minimal risk determination, and based on different criteria.)  

See also:
FDA educational video “CDRH Regulated Software: An Introduction
FDA Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies
FDA "Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices - Information Sheet
FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices:
Guidance for Industry and FDA Staff: Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices