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110 2 a| Institute of Medicine (U.S.).b| Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process.=| ^A1333499;

245 10 a| Medical devices and the public's healthh| [electronic resource] :b| the FDA 510(k) clearance process at 35 years /c| Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies.;

260 a| Washington, D.C. :b| National Academies Press,;

300 a| xx, 298 p. :b| ill. ;c| 23 cm.;

504 a| Includes bibliographical references and index.;

505 0 a| 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.;

506 a| Available only to authorized users.;

520 a| "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.;

530 a| Also available online in Open Book format via the National Academies Press home page.;

538 a| Mode of access: World Wide Web;

610 12 a| United States.b| Food and Drug Administration.=| ^A1253;

650 0 a| Medical instruments and apparatus.=| ^A3247;

650 0 a| Medical instruments and apparatusx| Safety regulationsz| United States.=| ^A420502;

650 0 a| Product safetyx| Law and legislationz| United States.=| ^A119966;

650 12 a| Equipment and Suppliesx| standardsz| United States.=| ^A923321;

650 22 a| Device Approvalx| legislation & jurisprudencez| United States.=| ^A1337250;

650 22 a| Equipment Safetyz| United States.=| ^A920638;

655 0 a| Electronic books.=| ^A491897;

856 40 z| Full text available from Ebook Central - Academic Completeu| https://ebookcentral.proquest.com/lib/eastcarolina/detail.action?docID=3378915;

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Medical devices and the public's health the FDA 510(k) clearance process at 35 years / Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies.

Author/creator	Institute of Medicine (U.S.).
Format	Electronic
Publication Info	Washington, D.C. : National Academies Press,
Description	xx, 298 p. : ill. ; 23 cm.
Supplemental Content	Full text available from Ebook Central - Academic Complete
Subjects	United States. Food and Drug Administration. Medical instruments and apparatus. Medical instruments and apparatus--Safety regulations. --United States. Product safety--Law and legislation. --United States. Equipment and Supplies--standards. --United States. Device Approval--legislation & jurisprudence. --United States. Equipment Safety--United States.

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.
Abstract	"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 note	Includes bibliographical references and index.
Access restriction	Available only to authorized users.
Other forms	Also available online in Open Book format via the National Academies Press home page.
Technical details	Mode of access: World Wide Web
Genre/form	Electronic books.
LCCN	2011277317
ISBN	9780309212427 (pbk.)
ISBN	0309212421 (pbk.)

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Medical devices and the public's health the FDA 510(k) clearance process at 35 years / Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies.

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