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Medical devices and the public's health : the FDA 510(k) clearance process at 35 years /
"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 device...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor Corporativo: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Washington, D.C. :
National Academies Press,
©2011.
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| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 110 | 2 | |a Institute of Medicine (U.S.). |b Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process. | |
| 245 | 1 | 0 | |a Medical devices and the public's health : |b the FDA 510(k) clearance process at 35 years / |c Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies. |
| 246 | 3 | 0 | |a FDA 510(k) clearance process at 35 years |
| 246 | 3 | |a Food and Drug Administration 510(k) clearance process at 35 years | |
| 260 | |a Washington, D.C. : |b National Academies Press, |c ©2011. | ||
| 300 | |a 1 online resource (xx, 298 pages) : |b illustrations | ||
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| 520 | |a "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"--Publisher's description | ||
| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | 0 | |t Introduction -- |t Key medical-device legislative and regulatory actions -- |t Components of US medical-device regulation -- |t The 510(k) clearance process -- |t Postmarketing surveillance, compliance, and enforcement -- |t External factors that affect the medical-device regulatory system -- |t Conclusions and recommendations -- |t A history of medical-device legislation and regulation in the United States. |
| 536 | |a Supported by the National Academy of Sciences and the Department of Health and Human Services |b HHSF223200810020I |g 13 | ||
| 588 | 0 | |a Online resource; title from resource title page (National Academies Press, viewed November 7, 2011). | |
| 590 | |a ProQuest Ebook Central |b Ebook Central Academic Complete | ||
| 650 | 0 | |a Medical instruments and apparatus. | |
| 650 | 0 | |a Medical instruments and apparatus |x Safety regulations |z United States. | |
| 650 | 0 | |a Product safety |x Law and legislation |z United States. | |
| 650 | 2 | |a United States Food and Drug Administration | |
| 650 | 1 | 2 | |a Device Approval |x standards |
| 650 | 1 | 2 | |a Equipment Safety |x standards |
| 650 | 2 | 2 | |a Device Approval |x legislation & jurisprudence |
| 650 | 2 | 2 | |a Device Approval |
| 650 | 2 | 2 | |a Product Surveillance, Postmarketing |x methods |
| 651 | 2 | |a United States | |
| 650 | 2 | |a Equipment and Supplies | |
| 650 | 6 | |a Médecine |x Appareils et instruments. | |
| 650 | 6 | |a Médecine |x Appareils et instruments |x Sécurité |x Règlements |z États-Unis. | |
| 650 | 7 | |a MEDICAL |x Allied Health Services |x Medical Technology. |2 bisacsh | |
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| 651 | 7 | |a United States |2 fast |1 https://id.oclc.org/worldcat/entity/E39PBJtxgQXMWqmjMjjwXRHgrq | |
| 758 | |i has work: |a Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years (Text) |1 https://id.oclc.org/worldcat/entity/E39PCXwxD6gtPmQ9yk6gFfVcj3 |4 https://id.oclc.org/worldcat/ontology/hasWork | ||
| 776 | 0 | 8 | |i Print version: |a Institute of Medicine (U.S.). Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process. |t Medical devices and the public's health. |d Washington, D.C. : National Academies Press, ©2011 |z 9780309212427 |w (DLC) 2011277317 |w (OCoLC)747314134 |
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