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
Get Book Here
Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309133947
Category : Medical
Languages : en
Pages : 346
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Book Description
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Author: I. Glenn Cohen
Publisher: Cambridge University Press
ISBN: 1108838634
Category : Law
Languages : en
Pages : 295
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Book Description
A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
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: 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: 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: Robert I. Field
Publisher: Oxford University Press, USA
ISBN: 0195159683
Category : Medical
Languages : en
Pages : 353
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Book Description
Regulation shapes all aspects of America's fragmented health care industry. While the health and lives of patients as well as almost one-sixth of the national economy depend on its effectiveness, health care regulation in America is bewilderingly complex. 'Health Care Regulation in America' is a guide to this regulatory maze.
Author: G.R Higson
Publisher: CRC Press
ISBN: 1420033980
Category : Medical
Languages : en
Pages : 278
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Book Description
Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212456
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: Kieran Walshe
Publisher: McGraw-Hill Education (UK)
ISBN: 0335228283
Category : Medical
Languages : en
Pages : 276
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Book Description
Healthcare organizations in the UK and the USA face a growing tide of regulation, accreditation, inspection and external review, all aimed at improving their performance. In the US, over three decades of regulation by state and federal government, and by non-governmental agencies, has created a complex, costly and overlapping network of oversight arrangements for healthcare organizations. In the UK, regulation of the government-run National Health Service is central to current health policy, with the creation of a host of new national agencies and inspectorates tasked with overseeing the performance of NHS hospitals and other organizations. But does regulation work? This book: . explores the development and use of healthcare regulation in both countries, comparing and contrasting their experience and drawing on regulatory research in other industries and settings . offers a structured approach to analysing what regulators do and how they work . develops principles for effective regulation, aimed at maximising the benefits of regulatory interventions and minimising their costs Regulating Healthcare is aimed at all with an interest or involvement in health policy and management, be they policy makers, healthcare managers or health professionals. It is particularly suitable for use on postgraduate health and health-related programmes.
