 | Yadin David, Wolf W. von Maltzahn, Michael R. Neuman, Joseph D. Bronzino - 2003 - 466 pages
...medical device is defined by Section 201 of the Federal Food, Drug, and Cosmetic Act (as amended), as an: instrument, apparatus, implement, machine, contrivance,...article including any component, part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopeia, or any... | |
 | J.E. Ellingsen, S.P. Lyngstadaas - 2003 - 467 pages
...studies may then be required. 21.2 Definitions of Medical Devices The FD&C defines a medical device as an instrument, apparatus, implement, machine, contrivance,...reagent, or other similar or related article, including a component, part or accessory, which is: 1. Recognized in the official National Formulary or the US... | |
 | Shayne C. Gad - 2003 - 189 pages
...Class I or II (through the 510(k) process); or • FDA reclassifies the device into Class I or II. machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component, part, or accessory that is • Recognized in the official National Formulary, or the United... | |
 | Davis Baird, Alfred Nordmann, Joachim Schummer - 2004 - 340 pages
...(A), (B), or (C). (quoted in Fiedler and Reynolds 1994, pp. 607-8) And a device is defined as: [A]n 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... | |
 | Richard R. Abood, David B. Brushwood - 2005 - 396 pages
...processor, packer, or distributor. [§ 201(g); 21 USC § 321(g)] (h) 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 Pharmacopoeia,... | |
 | John C. Miller, Ruben Serrato, Jose Miguel Represas-Cardenas, Griffith Kundahl - 2004 - 384 pages
...Radiological Health (CDRH) is responsible for regulating medical devices.23 A device is defined as: 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 Pharmacopoeia, or... | |
 | Lynn D. Fleisher, James C. Dechene - 2004 - 708 pages
...of the Federal Food, Drug, and Cosmetic Act, 21 USC § 301 ct seq., 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 Pharmacopoeia,... | |
 | Jose Justiniano, Venky Gopalaswamy - 2004 - 152 pages
...answer by addressing them in a proactive mode as much as possible. What is a medical device? "...an instrument, apparatus, implement, machine, contrivance,...reagent, or other similar or related article, including a component, part, or accessory, which is: • Recognized in the official National Formulary, or the... | |
 | Alan B. Cohen, Ruth S. Hanft - 2004 - 494 pages
...and includes both premarket review and postmarket surveillance. A device is defined broadly as any "instrument, apparatus, implement, machine, contrivance,...vitro reagent, or other similar or related article" that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and... | |
 | Joseph F. Dyro - 2004 - 696 pages
...the official National Formulary, or in the United States Pharmacopoeia, or any supplement to them; 2. Intended for use in the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, in man or other animals; or 3. Intended... | |
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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... 
