Medical Devices Law and Regulation Answer Book PDF Download
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Author: Suzan Onel
Publisher:
ISBN: 9781402441622
Category : Medical instruments and apparatus
Languages : en
Pages : 0
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Book Description
Author: Suzan Onel
Publisher:
ISBN: 9781402441622
Category : Medical instruments and apparatus
Languages : en
Pages : 0
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141
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Book Description
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Author: Committee for the Study of the Future of Public Health
Publisher: National Academies Press
ISBN: 0309581907
Category : Medical
Languages : en
Pages : 240
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Book Description
"The Nation has lost sight of its public health goals and has allowed the system of public health to fall into 'disarray'," from The Future of Public Health. This startling book contains proposals for ensuring that public health service programs are efficient and effective enough to deal not only with the topics of today, but also with those of tomorrow. In addition, the authors make recommendations for core functions in public health assessment, policy development, and service assurances, and identify the level of government--federal, state, and local--at which these functions would best be handled.
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133181
Category : Medical
Languages : en
Pages : 536
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Book Description
The anthrax incidents following the 9/11 terrorist attacks put the spotlight on the nation's public health agencies, placing it under an unprecedented scrutiny that added new dimensions to the complex issues considered in this report. The Future of the Public's Health in the 21st Century reaffirms the vision of Healthy People 2010, and outlines a systems approach to assuring the nation's health in practice, research, and policy. This approach focuses on joining the unique resources and perspectives of diverse sectors and entities and challenges these groups to work in a concerted, strategic way to promote and protect the public's health. Focusing on diverse partnerships as the framework for public health, the book discusses: The need for a shift from an individual to a population-based approach in practice, research, policy, and community engagement. The status of the governmental public health infrastructure and what needs to be improved, including its interface with the health care delivery system. The roles nongovernment actors, such as academia, business, local communities and the media can play in creating a healthy nation. Providing an accessible analysis, this book will be important to public health policy-makers and practitioners, business and community leaders, health advocates, educators and journalists.
Author: Judy Allsop
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 264
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Book Description
Examines the formal and informal regulations of medical work in the health service. The text explores two major issues - firstly the boundaries between state-sanctioned self regulation and other regulatory systems, secondly, the relationship between formal and informal controls.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309208955
Category : Medical
Languages : en
Pages : 700
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Book Description
The Future of Nursing explores how nurses' roles, responsibilities, and education should change significantly to meet the increased demand for care that will be created by health care reform and to advance improvements in America's increasingly complex health system. At more than 3 million in number, nurses make up the single largest segment of the health care work force. They also spend the greatest amount of time in delivering patient care as a profession. Nurses therefore have valuable insights and unique abilities to contribute as partners with other health care professionals in improving the quality and safety of care as envisioned in the Affordable Care Act (ACA) enacted this year. Nurses should be fully engaged with other health professionals and assume leadership roles in redesigning care in the United States. To ensure its members are well-prepared, the profession should institute residency training for nurses, increase the percentage of nurses who attain a bachelor's degree to 80 percent by 2020, and double the number who pursue doctorates. Furthermore, regulatory and institutional obstacles-including limits on nurses' scope of practice-should be removed so that the health system can reap the full benefit of nurses' training, skills, and knowledge in patient care. In this book, the Institute of Medicine makes recommendations for an action-oriented blueprint for the future of nursing.
Author:
Publisher:
ISBN:
Category : Employer-sponsored health insurance
Languages : en
Pages : 88
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Book Description
Author: David A. Johnson
Publisher: Federation of State Medical Boards
ISBN: 0739174401
Category : Medical
Languages : en
Pages : 391
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Book Description
Medical Licensing and Discipline in America traces the evolution of the U.S. medical licensing system from its historical antecedents in the 18th and 19th century to its modern structure. David A. Johnson and Humayun J. Chaudhry provide an organizational history of the Federation of State Medical Boards within the broader context of the development of America’s state-based system. As the national organization representing the interests of the individual state medical boards, the Federation has been at the forefront of developments in licensing, discipline, and regulation impacting the medical profession, medical education, and health policy within the United States. The narrative shifts between micro- and macro-level developments in the evolution of America’s medical licensing system, blending national context with state-specific and Federation initiatives. For example, the book documents such milestones as the national shift toward greater public accountability by state medical boards as evidenced by California’s inclusion of public members on its medical board, New Mexico’s requirement for continuing medical education by physicians as a condition for license renewal and the Federation’s policy development work advocating for both initiatives among all state medical boards. The book begins by examining the 18th and 19th century origins of the modern state-based medical regulatory system, including the reinstitution of licensing boards in the latter part of the 19th century and the early challenges facing boards, e.g., license portability, examinations, physician impostors, inter-professional tensions among physicians, etc. Medical Licensing and Discipline in America picks up the story of the Federation and its role in the major issue of licensing and discipline in the 20th century: uniformity in medical statute, evaluation of international medical graduates, nationally administered examinations for licensure, etc.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309113695
Category : Medical
Languages : en
Pages : 202
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Book Description
Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.
