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To determine whether or not FDA regulations apply to your study, consider the three questions below. Answering 'yes' to all three questions indicates FDA regulations do apply

1. Is your study evaluating what the FDA considers to be a test article?

A test article is defined by the FDA as:

  • Drugs or biologics; any substance that is described by one of the following:
    • intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease;
    • intended to affect the structure or any function of the body (not including food)
    • a substance intended for use as a component of a medicine

Note: Dietary supplements, foods, and other ingestibles are considered 'drugs' if they are utilized to diagnose, cure, treat, mitigate, or prevent a disease or condition.

  • Devices: an instrument that can be described by one of the following:
    • Intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or other conditions
    • Intended to affect the structure or any function of the body

Note: Some software, wearable technology, exercise devices, et al. may be classified as a medical device.  Please refer to the FDA guidance on Digital Health Content for more information.

2. Are you conducting a clinical investigation?

A clinical investigation, as defined by the FDA, is "any experiment that involves a test article and one or more human subjects"

3. Does your activity (research) involve human subjects?

The FDA defines human subjects as "an individual who is, or becomes, a participant in research, either as a recipient of the test article or as a control"

Note: de-identified human biological specimens used in this type of study qualifies as a human subject

If you answered 'yes' to all three of the above questions, then your research is FDA-regulated.

FDA Guidance Documents

FDA Regulations

The Code of Federal Regulations (CFR) Title 21 CFR is specific to rules and regulations of the FDA. Regulations pertaining to human subjects research include:

Helpful Links

Regulatory language may be difficult to understand, especially for those who are new to reading these types of documents.  However, it is mandatory that researchers and study teams understand the complex regulations surrounding IND/IDE trials.  The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) site provides excellent guidance that many find accessible, and we recomnmend research teams start there.