Medical Devices Standard Activities Report Medical Devices Us Department Of Health Human Services 1994 PDF Download
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Author | : National Center for Devices and Radiological Health (U.S.) |
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Download Medical Devices Standard Activities Report, Medical Devices, U.S. Department of Health & Human Services, 1994 Book in PDF, ePub and Kindle
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Total Pages | : 152 |
Release | : 1987 |
Genre | : Medical instruments and apparatus |
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Download Medical Devices Standards Activities Report Book in PDF, ePub and Kindle
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 318 |
Release | : 2011-10-25 |
Genre | : Medical |
ISBN | : 0309212456 |
Download Medical Devices and the Public's Health Book in PDF, ePub and Kindle
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.
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Total Pages | : 184 |
Release | : 1989 |
Genre | : Medical instruments and apparatus |
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Download Medical Devices Standards Activities Report Book in PDF, ePub and Kindle
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Total Pages | : 872 |
Release | : 1994-08 |
Genre | : Government publications |
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Download Monthly Catalogue, United States Public Documents Book in PDF, ePub and Kindle
Author | : United States. Department of Health and Human Services |
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Total Pages | : 516 |
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Genre | : Government publications |
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Download Publication Catalog of the U.S. Department of Health and Human Services Book in PDF, ePub and Kindle
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Total Pages | : 1168 |
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Genre | : Government publications |
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Download Monthly Catalog of United States Government Publications Book in PDF, ePub and Kindle
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Total Pages | : 4 |
Release | : 1994 |
Genre | : Medical instruments and apparatus |
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Download Medical Devices Bulletin Book in PDF, ePub and Kindle
Author | : World Health Organization |
Publisher | : World Health Organization |
Total Pages | : 147 |
Release | : 2010 |
Genre | : Medical |
ISBN | : 9241564040 |
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Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
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Total Pages | : 14 |
Release | : 1997 |
Genre | : Medical instruments and apparatus |
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Download Improving Patient Care by Reporting Problems with Medical Devices Book in PDF, ePub and Kindle