Medical Devices and the Public's Health

Medical Devices and the Public's Health PDF 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.

Medical Devices and the Public's Health

Medical Devices and the Public's Health PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318

Get Book Here

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.

Monthly Catalogue, United States Public Documents

Monthly Catalogue, United States Public Documents PDF Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 1316

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Book Description


Current Catalog

Current Catalog PDF Author: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 1120

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Book Description
First multi-year cumulation covers six years: 1965-70.

Monthly Catalog of United States Government Publications

Monthly Catalog of United States Government Publications PDF Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 502

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Subject Guide to U.S. Government Reference Sources

Subject Guide to U.S. Government Reference Sources PDF Author: Gayle J. Hardy (Davis)
Publisher: Bloomsbury Publishing USA
ISBN: 0313078661
Category : Language Arts & Disciplines
Languages : en
Pages : 381

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Book Description
Revised and updated, this compendium helps readers identify and understand the scope of key government reference sources-traditional books (including publications catalogs and telephone directories); information clearinghouses; and materials in new formats, such as CD-ROMs, datafiles, and Internet sites. The authors focus on free information and depository materials-both readily available through toll-free phone numbers, mail or e-mail requests to agencies, or federal depository library collections. Materials are fully described in annotations that differentiate between similar materials, identify typical citation formats, and note common abbreviations

CSU-FDA Collaborative Radiological Health Laboratory Annual Report

CSU-FDA Collaborative Radiological Health Laboratory Annual Report PDF Author: Collaborative Radiological Health Laboratory
Publisher:
ISBN:
Category :
Languages : en
Pages : 80

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Book Description
Contains reports on ongoing investigations being conducted by the Laboratory for its long-term study of the mortality, morbidity, and physiopathology of beagles exposed to a single low dose of ionizing radiation in utero or early in life.

National Library of Medicine Current Catalog

National Library of Medicine Current Catalog PDF Author: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 1000

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Book Description


New Serial Titles

New Serial Titles PDF Author:
Publisher:
ISBN:
Category : Periodicals
Languages : en
Pages : 2532

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Library & Information Sciences

Library & Information Sciences PDF Author:
Publisher:
ISBN:
Category : Library science
Languages : en
Pages : 732

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Book Description


Monthly Catalog of United States Government Publications

Monthly Catalog of United States Government Publications PDF Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 726

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Book Description