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" Pharmacopeia, or any supplement to them, (2) 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... "
Biomedical Ethics for Engineers: Ethics and Decision Making in Biomedical ... - Page 373
by Daniel A. Vallero - 2011 - 408 pages
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United States Code

United States - 1977
...paragraph (n) of this section and in sections 331(1), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance,...article, including any component, part, or accessory, which : (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any...
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A Compilation of Federal Laws Relating to Conservation and Development of ...

United States - 1977 - 933 pages
...used In paragraph (n) of this section and in sections 301 (1), 403(f). 502(c), and 602(c)) means an Instrument, apparatus, Implement, machine, contrivance,...article, including any component, part, or accessory, which is — (1) recognized in the official National Formulary, or the United States Pharmacopeia,...
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Compilation of Selected Acts Within the Jurisdiction of the Committee on ...

United States - 1977
...used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance,...article, including any component, part, or accessory, which is — (1) recognized in the official National Formulary, or the United States Pharmacopeia,...
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Preamble Compilation: Medical Devices, March 1936-March 1978

United States. Food and Drug Administration - 1981 - 420 pages
...this section and in secFood and Drug Administration tions 301U), 403(f). 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance,...article, including any component, part, or accessory, which is— ( 1 ) recognized in the official National Formulary, or the United States Pharmacopeia,...
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Economic Conditions in Agriculture and Fiscal Year 1984 Department of ...

United States. Congress. House. Committee on Agriculture - 1983 - 120 pages
...used in paragraph (n) of this section and in sections 301 (i), 403 (0, 502 (c), and 02 (c)) means an instrument, apparatus, implement, machine, contrivance,...article, including any component, part, or accessory, which is — (1) recognized in the official National Formulary, or the United States Pharmacopeia,...
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Agriculture, Rural Development, and Related Agencies Appropriations ..., Part 4

United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, and Related Agencies - 1983
...used in paragraph (n) of this section and in sections 301 (i), 403 (0, 502 (c), and 602 (c)) means an instrument, apparatus, implement, machine, contrivance,...article, including any component, part, or accessory, which is — (1) recognized in the official National Formulary, or the United States Pharmacopeia,...
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Agriculture, rural development, and related agencies appropriations ..., Part 4

United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, and Related Agencies - 1983
...used in paragraph (n) of this section and in sections 301 (i), 403 (0, 502 (c), and 602 (c)) means an instrument, apparatus, implement, machine, contrivance,...similar or related article, including any component, pan, or accessory, which is — (1) recognized in the official National Formulary, or the United States...
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Health and the Law: A Primer for Health Professionals

Tom Christoffel - 1985 - 468 pages
...does not include devices or their components, parts, or accessories."25 • device, which "means an instrument, apparatus, implement, machine, contrivance,...article, including any component, part, or accessory, which is — (1) recognized in the official National Formulary, or the United States Pharmacopeia,...
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Clinical Trials: Design, Conduct, and Analysis

Curtis L. Meinert, Susan Tonascia - 1986 - 469 pages
...the FDA to medical devices. A medical device is defined as (Food and Drug Administration, 1983): Any instrument, apparatus, implement, machine, contrivance,...reagent, or other similar or related article, including component, part, or accessory, which: • Is recognized in the official National Formulary, or the...
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Information Technologies in the Health Care System: Hearing Before ..., Volume 4

United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight - 1986 - 241 pages
...trying to apply the statute Is that computer programs do not fall clearly into the category of "an instrument, apparatus, implement, machine, contrivance,...vitro reagent, or other similar or related article." Clearly most of these terms cannot apply to programs, since they refer to a specific tangible item....
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