Individual

Individual means a natural living person who is a citizen of the United States or an alien lawfully admitted for permanent residence. Individual does not include sole proprietorships, partnerships, or corporations engaged in the production or distribution of products regulated by the Food and Drug Administration or with which the Food and Drug Administration has business dealings. Any such business enterprise that is identified by the name of one or more individuals is not an individual within the meaning of this part. Employees of regulated business enterprises are considered individuals. Accordingly, physicians and other health professionals who are engaged in business as proprietors of establishments regulated by the Food and Drug Administration are not considered individuals; however, physicians and other health professionals who are engaged in clinical investigations, employed by regulated enterprises, or the subjects of records concerning their own health, e.g., exposure to excessive radiation, are considered individuals. Food and Drug Administration employees, consultants, and advisory committee members, State and local officials, and consumers are considered individuals.

Source

21 CFR § 21.3


Scoping language

As used in this part:

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