scholarly journals Device Recalls and the Recalling Company's Website

2011 ◽  
Vol 45 (5) ◽  
pp. 412-415
Author(s):  
William A. Hyman
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Product Information ◽  
Close Association ◽  
Class I ◽  
Timely Manner ◽  
Web Presence ◽  
Other Information ◽  
The Right ◽  
The U.S

Abstract An ongoing issue with respect to medical device recalls is getting the information to the right people in a timely manner so that appropriate action can be taken. For Class I recalls, this is often addressed by one or more means of professional and public communications, including after-the-fact posting of such recalls by the U.S. Food and Drug Administration (FDA). One resource that could be included in a recall strategy is the recalling company's own website where the information could be readily available in close association with other information on the product, and where it would be readily found by someone making a product specific inquiry. However an investigation of 13 Class I recalls from the 4th quarter of 2010 shows that only four of these included a web presence, and even among these, the recall information was not necessarily easily found, nor closely linked, to other product information.

FDA regulation of labeling and promotional claims in therapeutic color vision devices: A tutorial

2004 ◽  
Vol 21 (3) ◽  
pp. 461-463 ◽  
Author(s):  
BRUCE DRUM
Keyword(s):  
Medical Device ◽  
Color Vision ◽  
Drug Administration ◽  
Scientific Evidence ◽  
Reading Performance ◽  
Device Performance ◽  
Medical Device Manufacturers ◽  
Intended Use ◽  
The U.S ◽  
Regulatory Challenges

The Food and Drug Administration (FDA) is responsible for determining whether medical device manufacturers have provided reasonable assurance, based on valid scientific evidence, that new devices are safe and effective for their intended use before they are introduced into the U.S. market. Most existing color vision devices pose so little risk that their manufacturers are not required to submit a premarket notification [510(k)] to FDA prior to market. However, even low-risk devices may not be acceptable if they are marketed on the basis of misleading or excessive claims. Although most color vision devices are diagnostic, two types that are therapeutic rather than diagnostic are colored lenses intended to improve deficient color vision and colored lenses intended to improve reading performance. Both of these devices have presented special regulatory challenges to FDA because the intended uses and effectiveness claims initially proposed by the manufacturers were not supported by valid scientific evidence. In each instance, however, FDA worked with the manufacturer to restrict labeling and promotional claims in ways that were consistent with the available device performance data and that allowed for the legal marketing of the device.

Recalls of Foods and Cosmetics by the U.S. Food and Drug Administration

1996 ◽  
Vol 59 (8) ◽  
pp. 876-880 ◽  
Author(s):  
RAJESH VENUGOPAL ◽  
LINDA TOLLEFSON ◽  
FREDERICK N. HYMAN ◽  
BAB TIMBO ◽  
RONALD E. JOYCE ◽  
...  
Keyword(s):  
Drug Administration ◽  
Microbial Contamination ◽  
Food And Drug Administration ◽  
Food Products ◽  
Class I ◽  
Regulatory Agencies ◽  
Health Consequences ◽  
Cooperative Effort ◽  
Adverse Health ◽  
The U.S

Recalls of foods and cosmetics from the marketplace are an expeditious and effective method of removing violative products, particularly those that present a danger to health. Recalls are undertaken through a cooperative effort by industry and the U.S. Food and Drug Administration (FDA). Foods and cosmetics recalled from the period 1 October 1991 through 30 September 1992 were reviewed to determine the kinds of products recalled and the reasons for recall. A total of 230 recalls, involving 569 foods and cosmetics, occurred during the study period. Twenty-eight percent of the recalls were designated class I, defined as a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences. The problems for which foods or cosmetics were most often recalled were misbranding and microbial contamination (37% and 25% of recalls, respectively). A recognized illness or injury was reported to have occurred in association with 32 food products and one cosmetic. This study indicates that recalls of foods and cosmetics are common and that various groups, including industry, consumers, state regulatory agencies, and the FDA, recognize problems leading to recall.

Guns on Campus: Surveying a rugged post-Heller/ McDonald landscape

2013 ◽  
Vol 45 (1-2) ◽  
pp. 77-108 ◽  
Author(s):  
Leif Magne Lervik
Keyword(s):  
Local Governments ◽  
Public Colleges ◽  
Concealed Weapons ◽  
Second Amendment ◽  
Academic History ◽  
Recent Developments ◽  
State And Local ◽  
Public Colleges And Universities ◽  
The Right ◽  
The U.S

In June 2008, the U.S. Supreme Court ruled that the Second Amendment to the U.S. Constitution guarantees an individual the right to keep and bear arms. Two years later, this decision was also made applicable to state and local governments. Today, seven U.S. states have provisions allowing the carrying of concealed weapons on their public senior high school campuses. This article, introduced by a brief comment on the Second Amendment’s legal and academic history, traces several recent developments of legal change. It discusses relevant arguments and attitudes towards guns on campus, and explores issues of future concern for public colleges and universities within the realm of firearms and campus safety.

HIV

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Research Process ◽  
National Institutes Of Health ◽  
Health Agencies ◽  
Act Up ◽  
The U.S

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.

The Economic and Political Determinants of Human (Including Health) Rights

1978 ◽  
Vol 8 (1) ◽  
pp. 145-168 ◽  
Author(s):  
Vicente Navarro
Keyword(s):  
Human Rights ◽  
Power Relations ◽  
Political Power ◽  
Political Rights ◽  
Individual Property ◽  
Socioeconomic Rights ◽  
Civil And Political Rights ◽  
Fair Wages ◽  
The Right ◽  
The U.S

This paper presents an analysis and critique of the U.S. government's current emphasis on human rights; and (a) its limited focus on only some civil and political components of the original U.N. Declaration of Human Rights, and (b) its disregard for economic and social rights such as the rights to work, fair wages, health, education, and social security. The paper discusses the reasons for that limited focus and argues that, contrary to what is widely presented in the media and academe: (1) civil and political rights are highly restricted in the U.S.; (2) those rights are further restricted in the U.S. when analyzed in their social and economic dimensions; (3) civil and political rights are not independent of but rather intrinsically related to and dependent on the existence of socioeconomic rights; (4) the definition of the nature and extension of human rights in their civil, political, social, and economic dimensions is not universal, but rather depends on the pattern of economic and political power relations particular to each society; and (5) the pattern of power relations in the U.S. society and the western system of power, based on the right to individual property and its concomitant class structure and relations, is incompatible with the full realization of human rights in their economic, social, political, and civil dimensions. This paper further indicates that U.S. financial and corporate capital, through its overwhelming influence over the organs of political power in the U.S. and over international bodies and agencies, is primarily responsible for the denial of the human rights of the U.S. population and many populations throughout the world as well.

Sign in / Sign up

Export Citation Format

Share Document