Medical device reporting improvements needed in FDA's system for monitoring problems with approved devices : report to congressional committees PDF Download
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Author:
Publisher: DIANE Publishing
ISBN: 1428978542
Category :
Languages : en
Pages : 60
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Book Description
Author:
Publisher: DIANE Publishing
ISBN: 1428978542
Category :
Languages : en
Pages : 60
Get Book Here
Book Description
Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 60
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Book Description
Author: U S Government Accountability Office (G
Publisher: BiblioGov
ISBN: 9781289113674
Category :
Languages : en
Pages : 64
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Book Description
The U.S. Government Accountability Office (GAO) is an independent agency that works for Congress. The GAO watches over Congress, and investigates how the federal government spends taxpayers dollars. The Comptroller General of the United States is the leader of the GAO, and is appointed to a 15-year term by the U.S. President. The GAO wants to support Congress, while at the same time doing right by the citizens of the United States. They audit, investigate, perform analyses, issue legal decisions and report anything that the government is doing. This is one of their reports.
Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 112
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Book Description
Author: United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources
Publisher:
ISBN:
Category : Social Science
Languages : en
Pages : 406
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Book Description
Author: Pascale Carayon
Publisher: CRC Press
ISBN: 1439830347
Category : Technology & Engineering
Languages : en
Pages : 855
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Book Description
The first edition of Handbook of Human Factors and Ergonomics in Health Care and Patient Safety took the medical and ergonomics communities by storm with in-depth coverage of human factors and ergonomics research, concepts, theories, models, methods, and interventions and how they can be applied in health care. Other books focus on particular human
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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Book Description
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309096316
Category : Medical
Languages : en
Pages : 481
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Book Description
Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.
Author: United States. Congress. House. Committee on Commerce. Subcommittee on Health and the Environment
Publisher:
ISBN:
Category : Consumer protection
Languages : en
Pages : 192
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Book Description
Author:
Publisher: DIANE Publishing
ISBN: 1428978488
Category :
Languages : en
Pages : 93
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Book Description
