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Medical Device Legislation 1975
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Author :United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment Publisher : ISBN 13 : Total Pages :252 pages Book Rating :4.3/5 ( download)
Book Synopsis Medical Device Legislation, 1975 by : United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment
Download or read book Medical Device Legislation, 1975 written by United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment and published by . This book was released on 1975 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Interstate and Foreign Commerce Publisher : ISBN 13 : Total Pages :240 pages Book Rating :4.F/5 ( download)
Book Synopsis Medical Device Legislation -- 1975, Prepared by the Staff the Use of the Subcommittee on Health and the Environment of ... , July 1975 by : United States. Congress. House. Committee on Interstate and Foreign Commerce
Download or read book Medical Device Legislation -- 1975, Prepared by the Staff the Use of the Subcommittee on Health and the Environment of ... , July 1975 written by United States. Congress. House. Committee on Interstate and Foreign Commerce and published by . This book was released on 1975 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Interstate and Foreign Commerce Publisher : ISBN 13 : Total Pages :566 pages Book Rating :4.F/5 ( download)
Book Synopsis Medical Device Amendments of 1975, Hearings Before the Subcommittee on Health and the Environment ..., 94-1, July 28, 29, 30, and 31, 1975 by : United States. Congress. House. Committee on Interstate and Foreign Commerce
Download or read book Medical Device Amendments of 1975, Hearings Before the Subcommittee on Health and the Environment ..., 94-1, July 28, 29, 30, and 31, 1975 written by United States. Congress. House. Committee on Interstate and Foreign Commerce and published by . This book was released on 1975 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis 1975 Medical Devices Legislation by : Commerce Clearing House
Download or read book 1975 Medical Devices Legislation written by Commerce Clearing House and published by . This book was released on 1975 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment Publisher : ISBN 13 : Total Pages :544 pages Book Rating :4.:/5 (41 download)
Book Synopsis Medical Device Amendments of 1975 by : United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment
Download or read book Medical Device Amendments of 1975 written by United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment and published by . This book was released on 1975 with total page 544 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment Publisher : ISBN 13 : Total Pages :522 pages Book Rating :4.:/5 (19 download)
Book Synopsis Medical Device Amendments of 1975 by : United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment
Download or read book Medical Device Amendments of 1975 written by United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment and published by . This book was released on 1975 with total page 522 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Medical Device Legislation by : Hospital Research and Testing Institute, Inc
Download or read book Medical Device Legislation written by Hospital Research and Testing Institute, Inc and published by . This book was released on 1975 with total page 71 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Medical Device Amendments of 1975 by : United States. Congress. Senate
Download or read book Medical Device Amendments of 1975 written by United States. Congress. Senate and published by . This book was released on 1975 with total page 79 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis An Analytical Legislative History of the Medical Device Amendments of 1976 by : Daniel F. O'Keefe
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:
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.
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.
Book Synopsis Proceedings of the Second Annual AAMI/FDA Conference on Medical Device Regulation, November 20-21, 1975, Washington by :
Download or read book Proceedings of the Second Annual AAMI/FDA Conference on Medical Device Regulation, November 20-21, 1975, Washington written by and published by . This book was released on 1976 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
Book Synopsis The Changing Economics of Medical Technology by : Institute of Medicine
Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Book Synopsis FDA Regulation of Medical Devices by : Judith A. Johnson
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.
Book Synopsis Monthly Catalog of United States Government Publications, Cumulative Index by : United States. Superintendent of Documents
Download or read book Monthly Catalog of United States Government Publications, Cumulative Index written by United States. Superintendent of Documents and published by . This book was released on 1976 with total page 1466 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Monthly Catalog of United States Government Publications by : United States. Superintendent of Documents
Download or read book Monthly Catalog of United States Government Publications written by United States. Superintendent of Documents and published by . This book was released on 1977 with total page 992 pages. Available in PDF, EPUB and Kindle. Book excerpt: February issue includes Appendix entitled Directory of United States Government periodicals and subscription publications; September issue includes List of depository libraries; June and December issues include semiannual index