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 Catalog of United States Government Publications

Monthly Catalog of United States Government Publications PDF Author: United States. Superintendent of Documents
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 1092

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Book Description
February issue includes Appendix entitled Directory of United States Government periodicals and subscription publications; September issue includes List of depository libraries; June and December issues include semiannual index

Current Catalog

Current Catalog PDF Author: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 1116

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

Food and Drug Regulation

Food and Drug Regulation PDF Author: ADAM I. MUCHMORE
Publisher:
ISBN: 9781531004453
Category :
Languages : en
Pages : 734

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Investigation of Allegations Relating to the Bureau of Drugs, Food and Drug Administration

Investigation of Allegations Relating to the Bureau of Drugs, Food and Drug Administration PDF Author: United States. Department of Health, Education, and Welfare. Review Panel on New Drug Regulation
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 796

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Monthly Catalog of United States Government Publications

Monthly Catalog of United States Government Publications PDF Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 1388

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Subject Catalog

Subject Catalog PDF Author: Library of Congress
Publisher:
ISBN:
Category :
Languages : en
Pages : 1072

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Oversight, the Food and Drug Administration's Process for Approving New Drugs

Oversight, the Food and Drug Administration's Process for Approving New Drugs PDF Author: United States. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 1324

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Food and Drug Administration Practice and Procedure, 1976

Food and Drug Administration Practice and Procedure, 1976 PDF Author: United States. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health
Publisher:
ISBN:
Category : Carcinogens
Languages : en
Pages : 482

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Library of Congress Catalogs

Library of Congress Catalogs PDF Author: Library of Congress
Publisher:
ISBN:
Category :
Languages : en
Pages : 1096

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Book Description