 | Christon J. Hurst - 1996 - 428 pages
...have followed. The current Act defines medical devices as follows: The term 'device' . . . 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, or... | |
 | International Validation Forum - 1996 - 860 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, or... | |
 | H. Lockhart, Frank A. Paine, Frank Albert Paine - 1996 - 236 pages
...The term device means an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent or other similar or related article, including any component part, or accessory which is: 0l recognised in the NF or the USP or any supplement (2l intended for use in the diagnosis... | |
 | United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and Investigations - 1996 - 218 pages
...Drug and Cosmetic Act (the Act) . Section 201(h)(2) of the Act states that the term "device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar related article, including any component, part, or accessory, which is intended for use in the diagnosis... | |
 | Howard H. Kaufman, Jeff L. Lewin - 1997 - 300 pages
...articles. Definition of a "Device" The Act, as amended in 1976, defines (not verbatim) a device as an instrument, apparatus, implement, machine, contrivance,...article, including any component part or accessory which meets any of the criteria for a drug given above, and which does not achieve any of its principle... | |
 | Buddy D. Ratner - 1996 - 500 pages
...Device Classification As defined in the 1976 Medical Device Amendments, a medical device is: . . . any instrument, apparatus, implement, machine, contrivance,...article, including any component, part, or accessory • which is recognized in the official National Formulary, or the US Pharmacopeia, or any supplement... | |
 | United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment - 1997 - 100 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,... | |
 | Anthony Atala, David J. Mooney - 1997 - 276 pages
...prevention of disease in man or other animals." Similarly, the term "device" is defined in the FDCA as "an instrument, apparatus, implement, machine, contrivance,...vitro reagent, or other similar or related article . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,... | |
 | United States. Congress. Senate. Special Committee on the Year 2000 Technology Problem - 1998 - 144 pages
...DEVICE? According to the definition in the Federal Food, Drug, and Cosmetic (FD&C) 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,... | |
 | United States. Congress. House. Committee on Veterans' Affairs. Subcommittee on Oversight and Investigations - 1998 - 120 pages
...According to the definition in the Federal Food, Drug, and Cosmetic Act (FDS.C 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... 
