Read full definition of a medical device defined by FDA. 

In short, a medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory.  

If it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, it is a medical device. 

If it is intended to affect the structure or any function of the body, and which does not achieve its primary intended purposes through chemical action and which is not dependent upon being metabolized for the achievement of its primary intended purposes, it is a medical device.  

Medical devices can range from Band-Aids to x-rays. It also includes in vitro diagnostics, software, and mobile applications; as well as items not typically considered medical devices, but because of how it is being used in a study, makes it a medical device. For example, a fitness watch that is being used in a study to reveal a medical or therapeutic change in the subject.  

In determining if your product is regulated as a medical device, it may also be helpful to search for existing product classifications that may apply to your product. For more information on how to search, see How to Determine if Your Product is a Medical Device. It is also advised to consult the IRB office prior to submitting your IRB application.  

  • If the device is investigational (not yet FDA approved), you must complete the subform.  
  • If you are studying an already FDA approved/cleared device (collecting safety/effectiveness data), and not simply using it to capture information for your study, you must complete the device subform.  
  • If you are using an FDA approved/cleared device in an off-label way (modifying its use for research purposes), you must complete the device subform.  
  • Device Brochures (required)  
    • The investigator’s brochure should be a comprehensive document of clinical and nonclinical data on the device, typically obtained through the FDA or the manufacturer of the device.    
    • If neither of these options are available, you will need to create your own investigator’s device brochure. This document should contain:  
      • what the device consists of;   
      • how the device works;   
      • recommendations on how to use it;   
      • risks and possible adverse events from the device;  
      • how long side effects from device may last;   
      • if reversibility is possible; and   
      • an optional picture or drawing of what the device looks like.  
  • Instructional Manuals  
  • Determination letter from the FDA, when applicable  
  • Other information from the manufacturer describing the device  
  • Reports of prior investigations with the device  

Not necessarily. The IRB may determine the medical device is exempt from the IDE regulations, or a non-significant risk medical device. These two categories do not require an IDE. Significant risk devices require an IDE. If the sponsor or FDA already determined it is a significant risk device, or fits into another category, please be sure to upload this determination to your IRB application.   

The FDA defines a significant risk device within this Information Sheet. The FDA does not define non-significant risk. If it is not exempt, then it is either significant risk or non-significant risk.  

Common exemptions include using an already approved device in an approved manner, and diagnostic devices that are noninvasive, minimal risk, does not introduce energy. While completing the device subform, you can indicate an exempt category for IRB review. See full list of exemptions at 812.2©. 

If it is already known the device needs an IDE (significant risk), or it needs a significant risk vs. nonsignificant risk determination, it must be reviewed by the board to make the determination. If FDA has already made the SR or NSR determination for the study, the agency's determination is final. Please upload this documentation.  

For studies that are exempt from the IDE regulations, the IRB does not need to decide whether the study poses a significant risk or nonsignificant risk so it is possible that exempt device studies may be eligible for expedited review if other activities occurring fall into an expedited category.

SR device studies must follow all the IDE regulations at 21 CFR 812. SR device studies must have an IDE application approved by FDA before they may proceed. You must also have IRB approval to proceed. When an IDE application is submitted by an investigator or sponsor to the FDA, the FDA has 30 days to respond and place a hold if necessary. If no hold is placed, the study may proceed. The IRB can open a study to enrollment after that 30-day window has passed. See additional information about FDA actions. 

NSR device studies must follow the abbreviated requirements at 21 CFR 812.2(b). These abbreviated requirements address labeling, IRB approval, informed consent, monitoring, records, reports, and prohibition against promotion. However, there is no need to make progress reports or final reports to FDA. NSR device studies do not have to have an IDE application approved by FDA.  

A HUD is a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or is manifested in fewer than 8,000 individuals in the United States per year. The MU IRB developed a policy for submitting and reviewing HUDs when they are not used in research. Read the policy. 

Please review the following guidance from the FDA and consult the IRB office for a determination. It is possible if you developed or are using software or an application to diagnose, cure, mitigate, treat, or prevent a disease or condition, it is a medical device.  

The guidance also provides examples of software functions that:   

  • are not medical devices,   
  • are medical devices, but for which the FDA intends to exercise enforcement discretion,  
    • For many software functions that meet the regulatory definition of a "device" but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretion and will not expect manufacturers to submit premarket review applications or to register and list their software with the FDA. The medical device subform still needs to be completed.  
  • and are medical devices and are the focus of FDA oversight.  

The study will still require MU IRB expedited review. Even if the specimens are not identifiable, the FDA requires an IRB to review the use of the in vitro diagnostic device. The device should fit into an IDE exemption for diagnostic devices. This part of the medical device subform must be completed with your IRB application.  

See Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable for more information.