scholarly journals CLASSIFICATION OF MEDICAL DEVICES AND PRIORITIES IN STANDARDIZATION IN THE UNITED STATES

1976 ◽  
Vol 46 (8) ◽  
pp. 382-389
Author(s):  
Harold Laufman
Keyword(s):  
United States ◽  
Medical Devices ◽  
The United States

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

scholarly journals Classification of Wetlands and Deepwater Habitats of the United States

2005 ◽  
Author(s):  
Lewis M. Cowardin ◽  
Virginia Carter ◽  
Francis C. Golet ◽  
Edward T. Laroe
Keyword(s):  
United States ◽  
The United States

Merchants of Asianness: Japanese Art Dealers in the United States in the Early Twentieth Century

2009 ◽  
Vol 44 (1) ◽  
pp. 19-46
Author(s):  
CONSTANCE J. S. CHEN
Keyword(s):  
United States ◽  
Cultural Capital ◽  
American Art ◽  
The United States ◽  
Racial Identities ◽  
Japanese Art ◽  
Art Dealers ◽  
Cultural Intermediaries

This article explores the role of Japanese merchants within American art and collecting circles and analyzes the ways in which the construction of “Asianness” and, in particular, “Japaneseness” became intertwined with the classification of Asian art. In order to reconstitute the market for high art and to create their own positionalities as legitimate cultural intermediaries, Asian art dealers such as Bunkio Matsuki (1867–1940) and Sadajiro Yamanaka (1866–1936) used their connections to Japan as cultural capital. Ultimately, their experiences illuminate the complexities of the reconceptualization of ethnic–racial identities through the lens of aesthetic discourses.

Assessing the Correlation of Culture With Business Ethics of Company Managers in the United States and Mexico

2018 ◽  
pp. 73-99
Author(s):  
Mark A. Anderson
Keyword(s):  
United States ◽  
National Culture ◽  
The United States ◽  
Business Managers ◽  
Ethical Attitudes ◽  
Cultural Elements ◽  
Management Scholar ◽  
Significant Difference

Observable harm has been inflicted upon business by unethical decisions and misconduct. Much of this phenomenon can be traced to impoverished ethical attitudes. Among the various reasons for this problem is that of a manager's culture, which has a distinct influence on attitudes and behaviors. The purpose of this chapter was to determine, through empirical data, whether differences rooted in culture significantly contribute to differences in ethical attitudes. Management scholar Geert Hofstede's classification of cultural elements for understanding and explaining aspects of national culture was correlated with the ethical attitudes of business managers in the two national cultures of the United States and Mexico. Results indicated a significant positive relationship between national culture and ethical attitudes and the dultural dimensions of uncertainty avoidance, masculinity, and long-term orientation. A significant difference in ethical attitudes between managers from the United States and Mexico was also found.

scholarly journals Influence of the syringe model on the results of the International Dysphagia Diet Standardisation initiative flow test

Revista CEFAC ◽  
2018 ◽  
Vol 20 (3) ◽  
pp. 382-387 ◽  
Author(s):  
Roberto Oliveira Dantas ◽  
Luciana Oliveira
Keyword(s):  
United States ◽  
Potassium Chloride ◽  
Flow Rate ◽  
Barium Sulfate ◽  
Xanthan Gum ◽  
The United States ◽  
Flow Test ◽  
Food Thickener

ABSTRACT Objective: to investigate whether two different syringes yield different results in the International Dysphagia Diet Standardization Initiative (IDDSI) flow test to evaluate liquid consistency. Methods: two 10-mL syringes (Bencton and Dickinson, manufactured in the United States, and Saldanha Rodrigues, manufactured in Brazil) were compared. Flow rate of water added with food thickener (maltodextrin, xanthan gum and potassium chloride) at three concentrations, and of barium sulfate at three concentrations was measured immediately after preparation and at 8 hours and 24 hours thereafter. Results: flow rate of both water and barium sulfate was higher with the Bencton and Dickinson syringe, with discrepancies between the two syringes in the classification of fluid consistency according to the IDDI framework. Conclusion: in the evaluation of the consistency of liquids by the IDDSI flow test, a Bencton and Dickinson syringe should be used, following the recommendations of the IDDSI group.

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