A Comparative Analysis of Medical Device Regulations in the EU and the USA

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Publisher : GRIN Verlag
ISBN 13 : 3668123217
Total Pages : 80 pages
Book Rating : 4.6/5 (681 download)

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Book Synopsis A Comparative Analysis of Medical Device Regulations in the EU and the USA by : Ann-Marie Jahn

Download or read book A Comparative Analysis of Medical Device Regulations in the EU and the USA written by Ann-Marie Jahn and published by GRIN Verlag. This book was released on 2016-01-12 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bachelor Thesis from the year 2012 in the subject Economy - Health Economics, grade: First, Berlin School of Economics and Law, language: English, abstract: Innovations in the medical device industry have improved the health of the world population with the ability to better diagnose, prevent, predict and cure illnesses. The number of medical devices on the market is increasing exponentially, together with the complexity, diversity and technical variation of such products. In light of its impact on patient health, regulation of medical devices is necessary to ensure that safe and effective products enter the marketplace, and that the product’s benefit to the patient population outweighs its potential risks. Although there has been increasing public scrutiny of health care reform, medical devices and their global regulation has been a minor field of health economic studies. This study examines the medical device regulatory systems and its impact on health care economics, exemplarily on the legislative programs of two major markets - the United States (U.S.) and European Union (EU). Modern medical device technology dates its origin to the early 19th century, but has grown most significantly in the last 50 years (Banta, p. 15). Today, 10,000 different families of medical device types exist with more than 400,000 different individual products on the market (Eucomed 2011). Outstanding developments have included heart-lung machines, artificial joints, as well as radiographic imaging and the means to perform advanced brain surgery. The medical device technology sector is extremely innovative, with seven out of ten major medical innovations in the last 40 years coming from this field (Fuchs, Sox, JR. 2001). Despite these technological advances, medical devices sometimes fail during use and can actually result in patient harm. The purpose of regulating medical equipment is to minimize the risk of harm to the end user and to prevent potentially unsafe products from entering the marketplace. The main obstacle in developing and implementing effective regulation is the term safety itself, as it can hardly be measured and there is no formula that can be consistently applied. Guidelines have been established that measure product risk, mitigate risks where possible, and then evaluate the residual risks to determine which are acceptable. This means by implication that acceptance of risk is part of the regulation process in order to bring life-saving technologies with unknown long-term effects to the market.

A New Model for European Medical Device Regulation

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Publisher : Europa Law Pub Netherlands
ISBN 13 : 9789089520524
Total Pages : 313 pages
Book Rating : 4.5/5 (25 download)

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Book Synopsis A New Model for European Medical Device Regulation by : Sharon Frank

Download or read book A New Model for European Medical Device Regulation written by Sharon Frank and published by Europa Law Pub Netherlands. This book was released on 2003-10 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses the regulation of medical devices at the federal level in the United States and in the European Union. It covers fundamental aspects (substantive and procedural) of the regulation of medical devices in both regimes, in order to assess the current European institutional framework. The author proposes regulatory reforms for the regulation of medical devices. It is suggested to create a new Community body, the European Medical Device Agency. The US Food and Drug Administration has served as a source of inspiration. This book gives answers to the question why a European Medical Device Agency is needed, its legal implications and its competences and structure (including how to organise all relevant parties concerned). It is proposed that the European Medical Device Agency should have a central role in the regulation of medical devices throughout the European Union. About the author: Sharon Frank (1972, Utrecht, the Netherlands) studied law at the Free University of Amsterdam, the University of Amsterdam, the Hebrew University in Jerusalem and Saint Louis University School of Law (US). From 1999-2002 she was a Ph.D candidate at the E.M.Meijers Institute for Legal Studies at Leyden University. In the frameworkof her Ph.D research, she visited the European University Institutein Florence in 2001. In 2000-2002 she was affiliated with the University of Amsterdam, lecturing European law at the Europa Institute and the Tulane-Amsterdam Summer School. Since 2003 she has been working at the Dutch Ministry of Justice.

A Systems Comparative Analysis of Medical Device Regulations in the United States, Canada, Australia, the European Union and Japan

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Publisher :
ISBN 13 :
Total Pages : 186 pages
Book Rating : 4.:/5 (783 download)

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Book Synopsis A Systems Comparative Analysis of Medical Device Regulations in the United States, Canada, Australia, the European Union and Japan by : Josephine M. Bautista

Download or read book A Systems Comparative Analysis of Medical Device Regulations in the United States, Canada, Australia, the European Union and Japan written by Josephine M. Bautista and published by . This book was released on 2012 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt:

How FDA is Causing a Technological Exodus

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Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (412 download)

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Book Synopsis How FDA is Causing a Technological Exodus by : Robert Higgs

Download or read book How FDA is Causing a Technological Exodus written by Robert Higgs and published by . This book was released on 1995 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Medical Devices

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Publisher : Woodhead Publishing
ISBN 13 : 0081002912
Total Pages : 253 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Medical Devices by : Seeram Ramakrishna

Download or read book Medical Devices written by Seeram Ramakrishna and published by Woodhead Publishing. This book was released on 2015-08-18 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process

Public Health Effectiveness of the FDA 510(k) Clearance Process

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Publisher : National Academies Press
ISBN 13 : 0309162904
Total Pages : 141 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine

Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

A Comparative Study of Medical Devices Regulatory Programs in Canada, the U.S.A., the U.K., Germany, the European Community, Australia, Japan

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Publisher :
ISBN 13 :
Total Pages : 119 pages
Book Rating : 4.:/5 (744 download)

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Book Synopsis A Comparative Study of Medical Devices Regulatory Programs in Canada, the U.S.A., the U.K., Germany, the European Community, Australia, Japan by : Canada. Medical Devices Review Committee. Secretariat

Download or read book A Comparative Study of Medical Devices Regulatory Programs in Canada, the U.S.A., the U.K., Germany, the European Community, Australia, Japan written by Canada. Medical Devices Review Committee. Secretariat and published by . This book was released on 1992 with total page 119 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Medical Devices and the Public's Health

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Publisher : National Academies Press
ISBN 13 : 0309212456
Total Pages : 318 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine

Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Device Regulation

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Publisher : BiblioGov
ISBN 13 : 9781289026547
Total Pages : 56 pages
Book Rating : 4.0/5 (265 download)

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Book Synopsis Medical Device Regulation by : U. S. Government Accountability Office (

Download or read book Medical Device Regulation written by U. S. Government Accountability Office ( and published by BiblioGov. This book was released on 2013-06 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pursuant to a congressional request, GAO compared the Food and Drug Administration's (FDA) and the European Union's (EU) systems for reviewing and approving medical devices, focusing on: (1) key differences between the two systems; (2) the outputs of the two systems; and (3) the feasibility of FDA adopting features of the EU system. GAO found that: (1) U.S. and EU medical device regulatory systems share the goal of protecting public health, but the EU system is designed to facilitate EU-wide trade; (2) while EU reviews medical devices for safety and performance, FDA reviews devices for safety, effectiveness, and benefit to patients; (3) while EU gives major medical device regulatory responsibilities to public agencies and private organizations, FDA has sole responsibility over device regulation in the United States; (4) both systems link the level of medical review to device risk, but the two systems use different procedures to reach approval or clearance decisions; (5) questions and concerns have arisen regarding possible conflicts-of-interest in the EU medical device review process because EU notified bodies carry out a regulatory function within the EU medical device system and conflict-of-interest rules for EU reviewers are less comprehensive than in the United States; (6) sufficient data does not exist on the EU medical device review system to permit meaningful comparison with FDA because the EU system is new and not yet fully operational; and (7) it is too early to evaluate the impact of new FDA streamlined review procedures.

Medical Device Regulations

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Publisher : World Health Organization
ISBN 13 : 9241546182
Total Pages : 54 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Medical Device Regulations by : Michael Cheng

Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

A review of UK health research funding

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Publisher : The Stationery Office
ISBN 13 : 0118404881
Total Pages : 132 pages
Book Rating : 4.1/5 (184 download)

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Book Synopsis A review of UK health research funding by : David Sir Cooksey

Download or read book A review of UK health research funding written by David Sir Cooksey and published by The Stationery Office. This book was released on 2006-12-06 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Review sets out to propose a structure for the funding arrangements for the whole spectrum of health research, with the objective of obtaining the maximum benefit from research success and, where possible, eliminating duplication of effort. The Review found, however, that the UK is at risk of failing to reap the full economic, health and social benefits that the UK's public investment in health research should generate. There is no overarching UK health research strategy to ensure UK health priorities are considered through all types of research and there are two key gaps in the translation of health research: (i) translating ideas from basic and clinical research into the development of new products and approaches to treatment of disease and illness; (ii) implementing those new products and approaches into clinical practice.The Review also found that the wider funding arrangements for supporting translation of ideas from conception to practice could be more coherent or comprehensive and, where arrangements exist, they do not function well. The Review identified cultural, institutional and financial barriers to translating research into practice in the publicly funded research arena. But it also found that, in the private sector, the pharmaceuticals industry is facing increasing challenges in translating research into health and economic benefit. The Review has sought to make recommendations that will increase the translation of R&D into health and economic benefit for the UK, both in the public and private sectors. The Review recommends that the Government should seek to achieve better coordination of health research and more coherent funding arrangements to support translation by establishing an Office for Strategic Coordination of Health Research (OSCHR).

The Regulation of Medical Devices

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Publisher :
ISBN 13 :
Total Pages : 218 pages
Book Rating : 4.:/5 (243 download)

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Book Synopsis The Regulation of Medical Devices by : Martine Carliese Pijnappels

Download or read book The Regulation of Medical Devices written by Martine Carliese Pijnappels and published by . This book was released on 1991 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Modern Methods of Clinical Investigation

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Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine

Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Evaluation of the Medical Device Approval Lag Between the United States and the European Union

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Publisher :
ISBN 13 :
Total Pages : 87 pages
Book Rating : 4.:/5 (769 download)

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Book Synopsis Evaluation of the Medical Device Approval Lag Between the United States and the European Union by : Todd V. Dhavale

Download or read book Evaluation of the Medical Device Approval Lag Between the United States and the European Union written by Todd V. Dhavale and published by . This book was released on 2011 with total page 87 pages. Available in PDF, EPUB and Kindle. Book excerpt: The United States is the world leader in development and manufacture of medical devices. Even with this leadership position, there is evidence that the US is often not the first country to have new medical technology approved for patient use. In many cases, the European Union is the first geographic region to approve a new medical technology for sale, with US approval coming later. This delay in approval of new devices between the EU and US is referred to as the "device lag." However, the extent or history of this lag over time and for different device types has not been examined. This thesis evaluated if a device approval lag has developed between US and EU at any time over the past 20 years and whether a device lag continues to exist today. US and EU regulatory approval data for 135 medical devices in three innovative medical device segments were collected and analyzed to evaluate the extent and history of the approval lag between the European Union and the United States. The collected approval data revealed a consistent approval lag between the US and EU in each of the three medical device segments explored in this study. Throughout the entire 20+ years of study, the United States had an average approval lag to the European Union in each of the three device segments, and an average lag for all devices of 21 months or almost 2 years (Ho: p. = 0, p = 8.2E-12). Furthermore, the device lag in these three segments has grown in recent years. These data are striking because they show, perhaps for the first time, that an approval lag has existed for medical devices between the US and EU for the past 20 years - since the beginning of the pan-European device regulatory system in the mid-1990s. The device lag is a useful metric for comparing the attractiveness of two markets for medical technology and may signal important changes in the medical technology industry. Furthermore, the existence of a persistent device approval lag in the United States may have significant implications for patients and their caregivers.

Assuring the Quality of Health Care in the European Union

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Publisher : World Health Organization
ISBN 13 : 9289071931
Total Pages : 242 pages
Book Rating : 4.2/5 (89 download)

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Book Synopsis Assuring the Quality of Health Care in the European Union by : Helena Legido-Quigley

Download or read book Assuring the Quality of Health Care in the European Union written by Helena Legido-Quigley and published by World Health Organization. This book was released on 2008 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.

Medical Devices

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Publisher : World Health Organization
ISBN 13 : 9241564040
Total Pages : 147 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Medical Devices by : World Health Organization

Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9

Healthcare Reference Book

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Publisher :
ISBN 13 : 9781592748952
Total Pages : 0 pages
Book Rating : 4.7/5 (489 download)

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Book Synopsis Healthcare Reference Book by : Mergent

Download or read book Healthcare Reference Book written by Mergent and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: