Introduction
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Products Regulated by the Food and Drug Administration (FDA)
The Food and Drug Administration (FDA) regulates all human subject research involving drugs, medical devices, and biologics, including the ingestion or injection of radio-labeled compounds. FDA regulations require IRB review and informed consent (21 CFR parts 56 and 50, respectively) in much the same way that the DHHS or DOE do. The following FDA definitions apply to research involving human subjects.
- "Research" as defined by FDA regulations means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations. [21 CFR 50.3(c), 21 CFR 56.102(c)].
- "Human Subject" as defined by FDA regulations means 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. [21 CFR 50.3(g), 21 CFR 56.102(e)].
- According to 21 CFR 812.3(p), a subject means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational devise is used or as a control. A subject may be in normal health or may have a medical condition or disease.
For additional information see FDA in Other Sites of Interest.
Note: Investigators should be aware that FDA regulations could apply when human tissue specimens are involved and the sponsor intends to send data to the FDA. See Defining Human Subject Research.
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