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U
(e)
(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains informat… +
(e) Institution means a person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to… +
(e) Sponsor means a person who initiates a clinical investigation, but who does not actually conduct the investigation, i.e., the test article is admi… +
(f) Institutional review board (IRB) means any board, committee, or other group formally designated by an institution to review biomedical research in… +
(f) Sponsor-investigator means an individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under who… +
(f)(1) Any device intended for human use which was not introduced or delivered for introduction into interstate commerce for commercial distribution b… +
(f)The term “food” means
(1) articles used for food or drink for man or other animals,
(2) chewing gum, and
(3) articles used for componen… +
(g) Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subjec… +
(g) Investigational device means a device, including a transitional device, that is the object of an investigation.… +
(h) Institution means any public or private entity or agency (including Federal, State, and other agencies). The word facility as used in section 520(… +
(h)(1) The term ‘‘device’’ (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means … +
(i) Institutional review board (IRB) means any board, committee, or other group formally designated by an institution to review biomedical research in… +
(i) Investigator means an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is adminis… +
(i)The term “cosmetic” means
(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the hu… +
(j) Monitor, when used as a noun, means an individual designated by a sponsor or contract research organization to oversee the progress of an investig… +
(j) Test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, ele… +
(k) Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate… +
(k) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than … +
(k) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than … +
(l) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospect… +
