Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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.
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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
Author: United States. Superintendent of Documents
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 1092
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
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 1092
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
Author: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 1568
Book Description
First multi-year cumulation covers six years: 1965-70.
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 1568
Book Description
First multi-year cumulation covers six years: 1965-70.
Food and Drug Regulation
Author: ADAM I. MUCHMORE
Publisher:
ISBN: 9781531004453
Category :
Languages : en
Pages : 734
Book Description
Publisher:
ISBN: 9781531004453
Category :
Languages : en
Pages : 734
Book Description
Investigation of Allegations Relating to the Bureau of Drugs, Food and Drug Administration
Author: United States. Department of Health, Education, and Welfare. Review Panel on New Drug Regulation
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 796
Book Description
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 796
Book Description
Oversight, the Food and Drug Administration's Process for Approving New Drugs
Author: United States. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 1324
Book Description
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 1324
Book Description
Monthly Catalog of United States Government Publications
Author:
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 1388
Book Description
Publisher:
ISBN:
Category : Government publications
Languages : en
Pages : 1388
Book Description
Subject Catalog
Author: Library of Congress
Publisher:
ISBN:
Category :
Languages : en
Pages : 1072
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages : 1072
Book Description
Food and Drug Administration Practice and Procedure, 1976
Author: United States. Congress. Senate. Committee on Labor and Public Welfare. Subcommittee on Health
Publisher:
ISBN:
Category : Carcinogens
Languages : en
Pages : 482
Book Description
Publisher:
ISBN:
Category : Carcinogens
Languages : en
Pages : 482
Book Description
Library of Congress Catalogs
Author: Library of Congress
Publisher:
ISBN:
Category :
Languages : en
Pages : 1096
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages : 1096
Book Description