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    Research Subject to FDA Regulation

    Q:  Is your research FDA-regulated?

    A:  YES, if you answer ‘yes’ to the following  I, II, and III questions:

     

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

    FDA considers the following to be test articles: (boldfaced content is for emphasis)

    • Articles that are considered drugs or biologics*, meaning any substance that is described by one of the following:
      • recognized by an official pharmacopoeia or formulary;
      • intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease;
      • (other than food) intended to affect the structure or any function of the body;
      • a substance intended for use as a component of a medicine (but not a device or a component, part or accessory of a device).

    * Dietary supplements, foods, and other substances may be considered drugs if they are being used to diagnose, cure, treat, mitigate, or prevent a disease or condition. Consult FDA Guidance for more information.

    • Articles that are considered devices*, meaning an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is described by one of the following: (boldfaced content is for emphasis)
    • Recognized by an official pharmacopoeia or formulary;
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or
    • intended to affect the structure or any function of the body

    and

    • which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

    * Certain software, wearable technology, exercise devices, and other products are sometimes classified as medical devices. See FDA’s Guidances with Digital Health Content for more information.

    II. Are you conducting a clinical investigation, defined by FDA as “any experiment that involves a test article and one or more human subjects…?”

    III. Does your activity involve human subjects, defined by FDA as “An individual who is, or becomes, a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient?”  (Note that human biological specimens, even if de-identified, used to test an investigational device (e.g., an assay), also constitute a human subject according to FDA.)

     

    Q:  If your research is subject to FDA regulations, which FDA regulations actually apply?

    A:  If you answered yes to I, II, and III above, it means that, along with any other required regulations that may govern your research, you must also comply with these FDA regulations:

    21 CFR 50 (Protection of Human Subjects)

    and

    21 CFR 56 (Institutional Review Boards)

    One of the changes in how you conduct the research is that you are required to make your study records available to FDA for inspection upon request, and you need to let your subjects know that too. The consent form templates on the UConn IRB Website have all the possible applicable sections you need to add for FDA-regulated research. These sections should be reviewed carefully because you must comply with what you tell your subjects (e.g., registering the study and reporting on study results on the clinicaltrials.gov website, inability for the subjects to remove their data if they withdraw from the study, etc.)

    Depending on the specifics of the research, additional FDA requirements may also apply, including (but not limited to) FDA-specific financial disclosure requirements, required application to the FDA for an IND (investigational new drug application), or required application to the FDA for an IDE (investigational device exemption). Increased regulatory responsibilities come with conducting studies under an IND or IDE; contact with the IRB Office is recommended as early as possible in the research development process to help ensure the researcher’s compliance with all applicable FDA regulations at all stages of the clinical investigation.

     

    Q:  Do you need more detail regarding when research is subject to FDA-regulation?

    A:  Please refer below to the following flowcharts and FDA guidance documents for more information about FDA-specific requirements, and when they apply to research activities: 

    FDA Flowchart

    FDA Flowchart – Special Topics

     

    FDA Guidances

    Drugs

    Devices