 | United States. Congress. Senate. Committee on Veterans' Affairs - 2000 - 204 pages
...adverse events. WHAT IS A MEDICAL DEVICE? According to the definition in the 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 - 2000 - 128 pages
...events. ' WHAT IS A MEDICAL DEVICE? According to the definition in the FDSC 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,... | |
 | Joseph D. Bronzino - 2000 - 1528 pages
...specifications and constraints relative to material-tissue interactions. Device: Defined by Congress as “...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,... | |
 | Robert V. Labaree - 2000 - 544 pages
...accessories. (d) Device 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,... | |
 | Seymour Stanton Block - 2001 - 1448 pages
...exposure to a microbicidal process. Medical device (as defined by the Food, Drug, and Cosmetic Act): 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 any... | |
 | Shayne C. Gad - 2001 - 424 pages
...States (US), according to 201 (h) of the Food, Drug and Cosmetic Act, a medical device is defined as an instrument, apparatus, implement, machine, contrivance,...reagent, or other similar or related article, including a component, part, or accessory that is: • recognized in the official National Formulary, or the... | |
 | Congress of the United States Office of - 2002 - 208 pages
...health objectives of the legislation (60). Device — The term "device" is defined in the FFDCA as "an instrument, apparatus, implement, machine, contrivance,...vitro reagent, or other similar or related article . . . which is ... intended for use in the diagnosis of disease or other conditions, or in the cure,... | |
 | Lawrence Ogalthorpe Gostin - 2002 - 582 pages
...31i(g)(1)(c). It defines "device," in part, as "an instrument, apparatus, implement, machine, contrivance, ... or other similar or related article, including any component, part, or accessory, which is ... intended to affect the structure or any function of the body." Id. at § 31i(h). The Act... | |
 | Sana Loue - 2007 - 235 pages
...be absorbed" (Food and Drug Administration, 1995a). The controlling statute defines a device as an instrument, apparatus, implement, machine, contrivance,...article, including any component, part, or accessory, which is- ... (3) intended to affect the structure or any function of the body of man or other animals,... | |
 | Ronald D. Mann, Elizabeth B. Andrews - 2003 - 587 pages
...perspective throughout the total product life cycle. ADDENDUM The definition of a medical device is: an instrument, apparatus, implement, machine, contrivance,...article, including any component, part, or accessory, which is: (1) recognized in the official National Formulary, or the US Pharmacopoeia, or any supplement... | |
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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... 
