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 FDA Annual Report written by United States. Food and Drug Administration and published by . This book was released on 1950 with total page 1176 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 Annual Reports 1950 1974 on the Administration of the Federal Food Drug and Cosmetic Act and Related Laws written by United States. Food and Drug Administration and published by . This book was released on 1976 with total page 1166 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Annual Report of the Office of Science and Technology written by Center for Devices and Radiological Health (U.S.). Office of Science and Technology and published by . This book was released on 1985 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book FDA Annual Report written by United States. Food and Drug Administration and published by . This book was released on 1973 with total page 774 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products written by and published by . This book was released on 1985 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Standards for the Growing Harvesting Packing and Holding of Produce for Human Consumption Us Food and Drug Administration Regulation Fda 2018 Edition written by The Law The Law Library and published by Createspace Independent Publishing Platform. This book was released on 2018-09-23 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA or we) is establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is establishing these standards as part of our implementation of the FDA Food Safety and Modernization Act. These standards do not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. We expect the rule to reduce foodborne illness associated with the consumption of contaminated produce. This book contains: - The complete text of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section
Download or read book Guide for Preparing Annual Reports on Radiation Safety Testing of Television Receivers written by and published by . This book was released on 1985 with total page 20 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 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 Annual Report written by United States. Food and Drug Administration and published by . This book was released on 1976 with total page 1166 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Code of Federal Regulations written by and published by . This book was released on 2003 with total page 736 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Department of Defense Chemical and Biological Defense Program Annual Report to Congress 2006 written by and published by DIANE Publishing. This book was released on with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Should FDA Drug and Medical Device Regulation Bar State Liability Claims written by United States. Congress. House. Committee on Oversight and Government Reform and published by . This book was released on 2010 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Radio Frequency Interference written by United States. Congress. Senate. Committee on Commerce, Science, and Transportation. Subcommittee on Communications and published by . This book was released on 1978 with total page 1374 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Radiation Health and Safety written by United States. Congress. Senate. Committee on Commerce, Science, and Transportation and published by . This book was released on 1977 with total page 1254 pages. Available in PDF, EPUB and Kindle. Book excerpt:
