 | United States. General Accounting Office - 1992 - 104 pages
...Cosmetic Act of 1938, as amended by the Medical Device Amendments of 1976, defines "medical device" as an instrument, apparatus, implement, machine, contrivance,...including any component, part, or accessory, that is (1) recognized in the official National Formulary or the US Pharmacopeia or any supplement to them;... | |
 | United States. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee - 1992 - 418 pages
...states that in accordance with the Federal Food, Drug and Cosmetic Act, a medical device is •. . .an instrument, apparatus, implement, machine, contrivance,...article, including any component, part, or accessory, which is . . other animals, and which does not achieve any of its principal intended purposes through... | |
 | 1993 - 56 pages
...Federal Food, Drug, and Cosmetic Act of 1938 (as amended by the Medical Device Amendments of 1976) as an instrument, apparatus, implement, machine, contrivance,...including any component, part, or accessory, that is recognized in the official National Formulary or the US Pharmacopeia or any supplement to them; that... | |
 | United States, United States. Congress. House. Committee on Energy and Commerce - 1993 - 476 pages
...when 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,... | |
 | Stanley Hoppenfeld, Michael S. Zeide - 1994 - 468 pages
...abduction or adduction relative to the midline or rotation from a starting point. Device (de-vis1) (n.) An instrument, apparatus, implement, machine, contrivance,...including any component, part, or accessory that is: 1. Recognized in the official National Formulary, the United States Pharmacopeia, or any supplements... | |
 | DIANE Publishing Company - 1994 - 226 pages
...403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, hi vitro reagent, or other similar or related article, including any component, part, or accessory, which i&— (1) recognized in the official National Formulary, or the United States Pharmacopeia, or... | |
 | Indra K. Reddy - 1995 - 618 pages
...lubricate mucous membrane surfaces and relieve dryness and irritation. Device the term device means an instrument, apparatus, implement, machine, contrivance,...article, including any component, part, or accessory, which is: (a) Recognized in the official National Formulary, or the United States Pharmacopeia, or... | |
 | United States - 1995 - 396 pages
...or accessories. (d) The term "device" (except when used in subsection (a) of this section) 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,... | |
 | United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and Investigations - 1996 - 352 pages
...Under the Federal Food, Drug and Cosmetic Act (FDCA), Section 201(h), a device is defined as: [A]n instrument, apparatus, implement, machine, contrivance,...article, including any component, part, or accessory, which is ... (2) intended for use in the diagnosis of disease or other conditions, or in the cure,... | |
 | Orrin G. Hatch - 1999 - 47 pages
...and dialysis equipment. According to the technical definition now found in the Act, a "device" is "an instrument, apparatus, implement, machine, contrivance,...article, including any component, part or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,... | |
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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... 
