Download or read book Safe Medical Devices Act of 1990 October 26 1990 Ordered to be Printed written by United States. Congress. House and published by . This book was released on 1990 with total page 30 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Safe Medical Devices Act of 1990 October 5 1990 Committed to the Committee of the Whole House on the State of the Union and Ordered to be Printed written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on 1990 with total page 81 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 Government Printing and Binding Regulations written by United States. Congress. Joint Committee on Printing and published by . This book was released on 1990 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Journal of the House of Representatives of the United States written by United States. Congress. House and published by . This book was released on 1974 with total page 1682 pages. Available in PDF, EPUB and Kindle. Book excerpt: Some vols. include supplemental journals of "such proceedings of the sessions, as, during the time they were depending, were ordered to be kept secret, and respecting which the injunction of secrecy was afterwards taken off by the order of the House."
Download or read book United States Code Congressional and Administrative News written by United States and published by . This book was released on 1991 with total page 2020 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contains laws, legislative history, administrative regulations, lists of committees, proclamations, executive messages and orders.
Download or read book Model Rules of Professional Conduct written by American Bar Association. House of Delegates and published by American Bar Association. This book was released on 2007 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
Download or read book United States Congressional Serial Set Catalog written by and published by . This book was released on 1988 with total page 756 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Cumulated Index Medicus written by and published by . This book was released on 1991 with total page 1384 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Front of Package Nutrition Rating Systems and Symbols written by Institute of Medicine and published by National Academies Press. This book was released on 2012-01-30 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the past decade, tremendous growth has occurred in the use of nutrition symbols and rating systems designed to summarize key nutritional aspects and characteristics of food products. These symbols and the systems that underlie them have become known as front-of-package (FOP) nutrition rating systems and symbols, even though the symbols themselves can be found anywhere on the front of a food package or on a retail shelf tag. Though not regulated and inconsistent in format, content, and criteria, FOP systems and symbols have the potential to provide useful guidance to consumers as well as maximize effectiveness. As a result, Congress directed the Centers for Disease Control and Prevention (CDC) to undertake a study with the Institute of Medicine (IOM) to examine and provide recommendations regarding FOP nutrition rating systems and symbols. The study was completed in two phases. Phase I focused primarily on the nutrition criteria underlying FOP systems. Phase II builds on the results of Phase I while focusing on aspects related to consumer understanding and behavior related to the development of a standardized FOP system. Front-of-Package Nutrition Rating Systems and Symbols focuses on Phase II of the study. The report addresses the potential benefits of a single, standardized front-label food guidance system regulated by the Food and Drug Administration, assesses which icons are most effective with consumer audiences, and considers the systems/icons that best promote health and how to maximize their use.
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 Federal Regulatory Guide written by CQ Press, and published by CQ Press. This book was released on 2024-06-11 with total page 1185 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Nineteenth Edition of the Federal Regulatory Directory is a comprehensive guide for understanding the complex world of federal regulation. It provides detailed profiles of the most important regulatory agencies, including their history, priorities, actions, and landmark decisions. The book also features overviews of independent and self-regulatory agencies, as well as the global and state-level impacts of federal regulation. Whether you are new to the topic or an expert, the Federal Regulatory Directory can be a valuable resource for students, researchers, professionals, and anyone who wants to understand how federal regulation works and how it affects their daily lives.
Download or read book Monthly Catalog of United States Government Publications written by and published by . This book was released on 1981 with total page 878 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Federal Register written by and published by . This book was released on 1989-10-18 with total page 1280 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book FDA Regulation of Medical Devices written by Judith A. Johnson and published by CreateSpace. This book was released on 2012-07-06 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt: On June 20, 2012, the House of Representatives passed, by voice vote and under suspension of the rules, S. 3187 (EAH), the Food and Drug Administration Safety and Innovation Act, as amended. This bill would reauthorize the FDA prescription drug and medical device user fee programs (which would otherwise expire on September 30, 2012), create new user fee programs for generic and biosimilar drug approvals, and make other revisions to other FDA drug and device approval processes. It reflects bicameral compromise on earlier versions of the bill (S. 3187 [ES], which passed the Senate on May 24, 2012, and H.R. 5651 [EH], which passed the House on May 30, 2012). The following CRS reports provide overview information on FDA's processes for approval and regulation of drugs: CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Susan Thaul; CRS Report RL33986, FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, by Susan Thaul; CRS Report R42130, FDA Regulation of Medical Devices, by Judith A. Johnson; CRS Report R42508, The FDA Medical Device User Fee Program, by Judith A. Johnson. (Note: The rest of this report has not been updated since December 28, 2011.) Prior to and since the passage of the Medical Device Amendments of 1976, Congress has debated how best to ensure that consumers have access, as quickly as possible, to new and improved medical devices and, at the same time, prevent devices that are not safe and effective from entering or remaining on the market. Medical devices regulation is complex, in part, because of the wide variety of items that are categorized as medical devices; examples range from a simple tongue depressor to a life-sustaining heart valve. The regulation of medical devices can affect their cost, quality, and availability in the health care system. In order to be legally marketed in the United States, many medical devices must be reviewed by the Food and Drug Administration (FDA), the agency responsible for protecting the public health by overseeing medical products, including devices. FDA's Center for Devices and Radiological Health (CDRH) is primarily responsible for medical device review. CDRH activities are funded through a combination of public money (i.e., direct FDA appropriations from Congress) and private money (i.e., user fees collected from device manufacturers) which together comprise FDA's total. User fees account for 33% of FDA's total FY2011 program level and 15% of CDRH's program level, which is $378 million in FY2011 including $56 million in user fees. FDA's authority to collect user fees, originally authorized in 2002 (P.L. 107-250), has been reauthorized in five-year increments. It will expire on October 1, 2012, under the terms of the Medical Device User Fee Act of 2007 (MDUFA), Title II of the FDA Amendments Act of 2007 (FDAAA, P.L. 110-85). FDA requires all medical product manufacturers to register their facilities, list their devices with FDA, and follow general controls requirements. FDA classifies devices according to the risk they pose to consumers. Premarket review is required for moderate- and high-risk devices. There are two paths that manufacturers can use to bring such devices to market. One path consists of conducting clinical studies, submitting a premarket approval (PMA) application and requires evidence providing reasonable assurance that the device is safe and effective. The other path involves submitting a 510(k) notification demonstrating that the device is substantially equivalent to a device already on the market (a predicate device) that does not require a PMA. The 510(k) process results in FDA clearance and tends to be much less expensive and less time- consuming than seeking FDA approval via PMA.
Download or read book Equipment for Older Or Disabled People and the Law written by Michael Mandelstam and published by Jessica Kingsley Publishers. This book was released on 1997 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive book explains the provision, both law and practice, of equipment and home adaptations to assist older or disabled people in daily living. Characterised by ill-defined statutory reponsibilities and terminology, and an under-developed consumer retail market, the system of provision has long been recognised as chaotic and confusing for professionals and public alike. This is despite the fact that equipment and adaptations are meant to be a central plank of community care. Necessarily wide-ranging but maintaining its focus, the book aims critically to describe the system and thereby promote better practice. By exploring boundaries and breaking points, it will assist people to understand the law when things go wrong - from negligence to judicial review, and from contract to product safety legislation. The range of items covered is great, from alarms to artificial limbs, baths to bedrooms, chopping boards to crutches, electronic toothbrushes to environmental controls, hearing aids to hoists, incontinence pads to ironing equipment, rails to ramps, speech aids to stairlifts, and walking frames to wheelchairs.
Download or read book Government reports annual index written by and published by . This book was released on 199? with total page 1322 pages. Available in PDF, EPUB and Kindle. Book excerpt:
