Download or read book Safe Medical Devices Act of 1990 A Legislative History of Public Law written by Reams and published by . This book was released on 1996 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Safe Medical Devices Act of 1990 A Legislative History of Public Law No 101 629 written by and published by . This book was released on 1996 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Safe Medical Devices Act of 1990 written by and published by . This book was released on 1996 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Safe Medical Devices Act of 1990 written by and published by . This book was released on 1996 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Legislative History of the Safe Medical Devices Act of 1990 written by and published by . This book was released on 1993 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Public Law 101 629 written by Center for Devices and Radiological Health (U.S.) and published by . This book was released on 1990* with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Highlights of the Safe Medical Devices Act of 1990 written by Center for Devices and Radiological Health (U.S.). Division of Small Manufacturers Assistance and published by . This book was released on 1991* with total page 13 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book An Analytical Legislative History of the Medical Device Amendments of 1976 written by Daniel F. O'Keefe and published by . This book was released on 1976 with total page 658 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 The Safe Medical Devices Act of 1990 written by Association for the Advancement of Medical Instrumentation and published by . This book was released on 1992-03 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Searching the Law 3d Edition written by Frank Bae and published by BRILL. This book was released on 2021-12-13 with total page 764 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Food and Drug Administration Advisory Committees written by Institute of Medicine and published by National Academies Press. This book was released on 1992-02-01 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.
Download or read book Priorities for the National Vaccine Plan written by Institute of Medicine and published by National Academies Press. This book was released on 2010-05-17 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vaccination is a fundamental component of preventive medicine and public health. The use of vaccines to prevent infectious diseases has resulted in dramatic decreases in disease, disability, and death in the United States and around the world. The current political, economic, and social environment presents both opportunities for and challenges to strengthening the U.S. system for developing, manufacturing, regulating, distributing, funding, and administering safe and effective vaccines for all people. Priorities for the National Vaccine Plan examines the extraordinarily complex vaccine enterprise, from research and development of new vaccines to financing and reimbursement of immunization services. Priorities for the National Vaccine Plan examines the extraordinarily complex vaccine enterprise, from research and development of new vaccines to financing and reimbursement of immunization services. The book makes recommendations about priority actions in the update to the National Vaccine Plan that are intended to achieve the objectives of disease prevention and enhancement of vaccine safety. It is centered on the plan's five goals in the areas of vaccine development, safety, communication, supply and use, and global health.
Download or read book United States Code written by United States and published by . This book was released on 2013 with total page 1506 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The United States Code is the official codification of the general and permanent laws of the United States of America. The Code was first published in 1926, and a new edition of the code has been published every six years since 1934. The 2012 edition of the Code incorporates laws enacted through the One Hundred Twelfth Congress, Second Session, the last of which was signed by the President on January 15, 2013. It does not include laws of the One Hundred Thirteenth Congress, First Session, enacted between January 2, 2013, the date it convened, and January 15, 2013. By statutory authority this edition may be cited "U.S.C. 2012 ed." As adopted in 1926, the Code established prima facie the general and permanent laws of the United States. The underlying statutes reprinted in the Code remained in effect and controlled over the Code in case of any discrepancy. In 1947, Congress began enacting individual titles of the Code into positive law. When a title is enacted into positive law, the underlying statutes are repealed and the title then becomes legal evidence of the law. Currently, 26 of the 51 titles in the Code have been so enacted. These are identified in the table of titles near the beginning of each volume. The Law Revision Counsel of the House of Representatives continues to prepare legislation pursuant to 2 U.S.C. 285b to enact the remainder of the Code, on a title-by-title basis, into positive law. The 2012 edition of the Code was prepared and published under the supervision of Ralph V. Seep, Law Revision Counsel. Grateful acknowledgment is made of the contributions by all who helped in this work, particularly the staffs of the Office of the Law Revision Counsel and the Government Printing Office"--Preface.
Download or read book Private Lives and Public Policies written by Panel on Confidentiality and Data Access and published by National Academies Press. This book was released on 1993-01-15 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans are increasingly concerned about the privacy of personal data--yet we demand more and more information for public decision making. This volume explores the seeming conflicts between privacy and data access, an issue of concern to federal statistical agencies collecting the data, research organizations using the data, and individuals providing the data. A panel of experts offers principles and specific recommendations for managing data and improving the balance between needed government use of data and the privacy of respondents. The volume examines factors such as the growth of computer technology, that are making confidentiality an increasingly critical problem. The volume explores how data collectors communicate with data providers, with a focus on informed consent to use data, and describes the legal and ethical obligations data users have toward individual subjects as well as toward the agencies providing the data. In the context of historical practices in the United States, Canada, and Sweden, statistical techniques for protecting individuals' identities are evaluated in detail. Legislative and regulatory restraints on access to data are examined, including a discussion about their effects on research. This volume will be an important and thought-provoking guide for policymakers and agencies working with statistics as well as researchers and concerned individuals.
