| Description |
1 online resource (xx, 298 pages) : illustrations |
| Physical Medium |
polychrome |
| Description |
text file |
| Summary |
"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. |
| Bibliography |
Includes bibliographical references and index. |
| Contents |
Introduction -- Key medical-device legislative and regulatory actions -- Components of US medical-device regulation -- The 510(k) clearance process -- Postmarketing surveillance, compliance, and enforcement -- External factors that affect the medical-device regulatory system -- Conclusions and recommendations -- A history of medical-device legislation and regulation in the United States. |
| Funding |
Supported by the National Academy of Sciences and the Department of Health and Human Services HHSF223200810020I 13 |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
United States. Food and Drug Administration. |
|
Medical instruments and apparatus.
|
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Medical instruments and apparatus. |
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Medical instruments and apparatus -- Safety regulations -- United States.
|
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Medical instruments and apparatus -- Safety regulations. |
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United States. |
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Product safety -- Law and legislation -- United States.
|
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Product safety -- Law and legislation. |
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Device Approval -- standards. |
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Equipment Safety -- standards. |
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Device Approval -- legislation & jurisprudence. |
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Device Approval. |
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Product Surveillance, Postmarketing -- methods. |
|
United States. |
| Genre/Form |
Electronic books.
|
|
Technical reports.
|
|
Technical reports.
|
| Added Title |
FDA 510(k) clearance process at 35 years |
|
Food and Drug Administration 510(k) clearance process at 35 years |
| Other Form: |
Print version: Institute of Medicine (U.S.). Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process. Medical devices and the public's health. Washington, D.C. : National Academies Press, ©2011 9780309212427 (DLC) 2011277317 (OCoLC)747314134 |
| ISBN |
9780309212434 (electronic book) |
|
030921243X (electronic book) |
|
128337627X |
|
9781283376273 |
|
9780309212427 |
|
0309212421 |
|
