Research with Drugs & Devices
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Human subjects research involving drugs/biologics and medical devices is subject to FDA regulations and oversight when the research meets the definition of a clinical investigation. The FDA has defined clinical investigation to be synonymous with research. The IRB will make the determination about the applicability of specific regulations based on interpretation of FDA regulations and the information provided by the researcher in the IRB application.
| Human Subject |
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| An individual who is or becomes a participant in research, either as a recipient of a test article or as a control. A subject may be either a healthy individual or a patient. 21 CFR 56.102(e) |
| Clinical Investigation |
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| Any research experiment that involves a test article and one or more human subjects and is subject to requirements for prior submission to the FDA (e.g., a change in labeling) or the results of the research (e.g., safety and efficacy) are intended to be submitted to the FDA as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for this definition. 21 CFR 56.102(c) |
| Test Article |
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| Any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to FDA regulation. 21 CFR 58.3(b) |
See information and guidance on Research with Drugs/Biologics and Research with Medical Devices on the following webpages.
For Information on Research with Drugs/Biologics:
Page updated June, 2026