Download or read book Medical Devices Law and Regulation Answer Book written by Susan Onel and published by . This book was released on 2016-11 with total page 1112 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
Download or read book Medical Devices Law and Regulation Answer written by Suzan Onel and published by Practising Law Inst. This book was released on 2012 with total page 1014 pages. Available in PDF, EPUB and Kindle. Book excerpt: The regulation of medical devices has grown increasingly complex since the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FDCA) were introduced in 1976. Medical Devices Law and Regulation Answer Book 2013 walks you through the current regulatory requirements and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation. With over 30 contributors from a variety of major law firms and consulting firms specializing in medical device work, Medical Devices Law and Regulation Answer Book 2013 provides practical guidance on how to handle every day questions on a wide variety of topics as well as what issues are likely to arise and how to avoid them. The breadth of coverage of this new publication is illustrated by the chapter titles provided below: Overview of Medical Device Regulation in the U.S. Clinical Studies of Investigational Devices Device Premarket Submissions Devices with Unique Issues Combination Devices, Radiological Devices, Restricted Devices, Customer Devices, Device Software In Vitro Diagnostic (IVD) Devices The Quality System Regulation Device Facility Inspections Post Market Considerations International Considerations Enforcement and Government Investigations Regarding Medical Devices Interacting with FDA Intellectual Property Considerations for Medical Device Companies Fraudulent and Abusive Practices in the Reimbursement for Medical Devices HIPAA s Impact on the Medical Device Manufacturing Community Continuing Medical Education (CME) and Industry-Supported Scientific Activities Litigation, Product Liability, and Preemption Licensing, Product Development and Commercialization FDA Criminal Enforcement Overlapping Jurisdiction with other Agencies and Law Enforcement Entities Commonly Used Acronyms"
Download or read book Medical Devices Law and Regulation Answer written by Karen Becker and published by Practising Law Inst. This book was released on 2011 with total page 960 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Medical Devices Law and Regulation Answer Book 2015 written by Suzan Onel and published by . This book was released on 2014-10-07 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The regulation of medical devices has grown increasingly complex since the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FDCA) were introduced in 1976. This title walks you through the current regulatory requirements and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation. Topics include: Overview of Medical Device Regulation in the U.S; Clinical Studies of Investigational Devices; Device Premarket Submissions; Devices with Unique Issues Combination Devices, Radiological Devices, Restricted Devices, Customer Devices, Device Software; Licensing, Product Development and Commercialization * FDA Criminal Enforcement * Overlapping Jurisdiction with other Agencies and Law Enforcement Entities * Commonly Used Acronyms"
Download or read book Medical Devices Law and Regulation Answer Book 2014 written by Suzan Onel and published by . This book was released on 2013-11-07 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The regulation of medical devices has grown increasingly complex since the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FDCA) were introduced in 1976. This title walks you through the current regulatory requirements and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation. Topics include: Overview of Medical Device Regulation in the U.S; Clinical Studies of Investigational Devices ; Device Premarket Submissions; Devices with Unique Issues - Combination Devices, Radiological Devices, Restricted Devices, Customer Devices, Device Software; Licensing, Product Development and Commercialization * FDA Criminal Enforcement * Overlapping Jurisdiction with other Agencies and Law Enforcement Entities * Commonly Used Acronyms"
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.
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.
Download or read book Medical Device Design and Regulation written by Carl T. DeMarco and published by Quality Press. This book was released on 2011-01-01 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2005-11-21 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.
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.
Download or read book Medical Device Development written by Jonathan S. Kahan and published by . This book was released on 2020 with total page 658 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Medical Device Regulations written by Aakash Deep and published by Academic Press. This book was released on 2022-01-13 with total page 187 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products
Download or read book New Medical Devices written by Institute of Medicine and published by National Academies Press. This book was released on 1988-01-01 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.
Download or read book Safe Medical Devices for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2006-01-20 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.
Download or read book Fundamentals of Medical Device Regulations Fourth Edition written by Gloria Hall and published by . This book was released on 2021-07-23 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Medical Product Regulatory Affairs written by John J. Tobin and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
Download or read book The Future of Medical Device Regulation written by I. Glenn Cohen and published by Cambridge University Press. This book was released on 2022-04-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardware. Regulation must keep pace with the current developments and controversies of this technology. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws. This book is also available as Open Access on Cambridge Core.
