Is It a Drug or Device? An Introduction to FDA Regulations and Human Research

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For investigators conducting research with outcomes aimed at “diagnosing, curing, treating, or mitigating a disease or condition,” the FDA’s Investigational New Drug (IND) regulations may apply more broadly than they think. The FDA’s definition of a drug reaches beyond simply prescription medications (though certainly such medications are also drugs) to include non-prescription drugs (like aspirin), biologics, dietary supplements, and food. (Read the full definition.) In the eyes of the FDA, foods, vitamins, or dietary supplements that are being used to “diagnose, cure, treat, or mitigate a disease or condition” can fall under IND regulations. An example of this would be a study looking at whether consumption of dried fruits could aid in the prevention of osteoporosis. There may be cases when a study involves prescription or non-prescription drugs but its purpose is not therapeutic—certain FDA regulations will still apply to such studies.  

 
In addition to requiring IRB approval, all applicable research using a drug as defined by the FDA must follow FDA regulations, regardless of whether a researcher is intending to bring a drug to market.  If a drug is used as part of a study protocol, as mentioned above, the study may require submission of an investigational new drug (IND) application. In some cases, it may be determined that a study is exempt from to the need to apply for an IND, but the FDA regulations at 21 CFR parts 50 and 56 still apply to the research and the researcher will need to include additional language in the informed consent form. For instance, the following would need to be incorporated into the informed consent form regardless of IND status:
•    the possibility that the Food and Drug Administration may inspect the records,
•    disclosure of appropriate alternate procedures or courses of treatment, if any, that might be advantageous to the subject.
University Park and Commonwealth researchers can find such language in HRP-587 “Additional Consent Requirements for Studies Involving the Use of Test Articles” in the CATS IRB Library.
 
Just as the definition of drugs is broad, so is the FDA’s definition of a medical device. The FDA defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article […] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.”  View the full definition. Items ranging from bandages to pregnancy tests to motorized wheelchairs to pacemakers are considered medical devices. Again, even if a researcher is not intending to bring the device to market, he/she may be subject to FDA regulations, including applying for an investigational device exemption (IDE). This allows “the investigational device to be used in a clinical study in order to collect safety and effectiveness data.” Provisions for informed consent and labeling of the device as investigational are required with an IDE.
 
The Office for Research Protections is here to help investigators wishing to pursue research that involves a drug or device, or potential drug or device, to navigate the FDA and its regulations. Our Quality Management Coordinator works one-on-one with investigators through the process of pursuing an IND or IDE, if needed.  For more information, visit the Quality Management website. If you have questions, contact us at qm-opr@psu.edu