FDA Regulated Research

Is your research FDA regulated?

1. When do the FDA regulations apply?

The FDA regulates research that involves food, dietary supplements, drugs, medical devices as well as electronic products to ensure that the data collected from these investigations was done so in an ethical, compliant, and sound manner before any product developed from the research is marketed and readily available to anyone.

2. How does the FDA define research?

FDA uses the term “Clinical Investigation” instead of “research”. This is different than the standard human subject regulations, also known as the Common Rule. A Clinical Investigation involves any experiment that involves a test article and one or more human subjects.

3. What is a test article?

Very simply put, a test article is the object or item under investigation. This might be a drug, device, or mobile health app, for example. 

The defining factor of when a drug or device is considered a “test article” is the reason for the research - Is the intent of the investigation to develop an object or item that will “cure, treat, mitigate, diagnose, or prevent disease in humans? Alternatively, is the intent of your investigation to develop an object or item that will affect the structure or any function of the body?” If your study has either of these intents, then the FDA regulations will most likely apply to your research.

Investigational Device

If the intent of your investigation is to develop a device that will cure, treat, mitigate, diagnose, prevent disease in humans OR affect the structure or any function of the body, please see section Investigational Device below for additional information on research involving medical investigational devices. 

A device that is used as a tool and is not the focus of the study is not subject to FDA IDE regulation. 

4. How do the FDA regulations define a human subject?

Human subject regulations under the Department of Health and Human Services (DHHS) often referred to as “The Common Rule” (45CFR46) define a human subject as a person that the researcher interacts or intervenes with. A human subject can also be private, identifiable data from a living person.

FDA regulations do not define a human subject in the same way. According to the FDA, a human subject is “an individual who is or becomes a participant in research, either as a recipient of a test article or control. A subject may be either a healthy human or a patient.” Notice that there is no mention of intervention or interaction or identifiable data, for that matter. The FDA definition of a human subject is much more broad.

For example, if you are using non-identifiable human blood to test a new diagnostic assay or test, that is a human subject according to the FDA.

5. What are some initial questions to think about?

  • Is the intent of your research to develop an object or item(for example, a drug, device, or biologic) that will cure, treat, mitigate, diagnose, prevent disease in humans OR affect the structure or any function of the body?
  • Will you be using people – either in person or something that came from a human, whether it is identifiable or not?
  • Do you plan on submitting data to the FDA at some time in the future?

6. What to do next?

The FDA regulations are quite complex and this is merely a simple overview to determine whether these regulations might apply to your research. The FDA regulations also differ whether your research involves a drug, biologic, or device.

COUHES is here to help with any question that you may have. Don’t hesitate to give us a call, email, or just stop by!

Investigational Devices

What is a Medical Device?

Any:

  • instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part or accessory 

Intended to: 

  • Diagnose disease or other conditions,
  • cure, mitigate, treat, or prevent disease, or
  • affect the structure or any function of the body of man

Which:

  • does not achieve its primary intended purposes through chemical action within or on the body, and
  • is not dependent upon being metabolized for the achievement of its primary intended purpose

Except:

  • FDCA §520(o)(1) excludes certain software functions from the term “device”

What is an Investigational Device?

A medical device that is the subject of a clinical study designed to evaluate the effectiveness and/or safety of the device. The device is still in the developmental stage and is not considered to be in commercial distribution.

What is an Investigational Device Exemption (IDE)?

An IDE allows for a device to be used in a clinical investigation and the exemption means that the device is exempt from laws that prohibit the unapproved products to move in interstate commerce.

The Is My Study Exempt? flowchart helps an investigator to determine whether a medical investigational device study is exempt from IDE, requiring full IDE, or abbreviated IDE. 

The Food and Drug Administration (FDA) IDE regulations [21 CFR 812] describe three types of device studies: 1) exempt, 2) significant risk (SR) and 3) nonsignificant risk (NSR). At MIT, device risk is determined by COUHES in consultation with the Office of the General Counsel, as necessary.

Significant Risk (SR) Devices presents a potential for serious risk to the health, safety, or welfare of a subject.

  • Implanted
  • Life-supporting or life sustaining
  • Devices intended for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health
  • Otherwise present a potential for serious risk to subjects

An IDE application must be submitted to the FDA if the device involved in the research is determined to be significant risk. SR devices require both FDA approval and IRB approval before the research can commence. All the requirements under [21 CFR 812] applies to a significant risk study. 

Nonsignificant Risk (NSR) Device: A NSR device is one that does not meet criteria for significant risk. NSR devices require approval from the IRB before initiating the research. In addition, PIs with nonsignificant risk (NSR) studies must comply with the abbreviated IDE requirements set forth in [21 CFR 812.2(b)].

Exempt Device Investigations: The FDA’s IDE regulations do not apply to exempt devices which include:

  • 510(k) device investigated in accordance with the FDA-cleared labeling (i.e., not off-label use)
  • A diagnostic device, if the testing:
    • Is noninvasive;
    • Does not require an invasive sampling procedure that presents significant risk,
    • Does not by design or intention introduce energy into a subject, and
    • Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure
  • “Consumer preference testing,” if the testing:
    • Is not for the purpose of determining safety or effectiveness, and 
    • Does not put subjects at risk
  • Device shipped solely for research on or with laboratory animals
  • “Custom device”

Approval from the IRB is required before initiating the research. (Note: Although exempt from 21CFR812, Exempt Device Investigations are still subject to 21CFR50 and 56). 

Each PI who uses an investigational medical device is responsible for control of the device in accordance with regulatory requirements. The PI is responsible for implementing the plan as approved by the IRB and/or FDA. 

Acknowledgment: Aspect of this page are based on material developed by the IRB at Harvard University. We appreciate their willingness to share the information.