Medical Devices and the Public's Health
Medical Devices and the Public's Health

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-11-25

Total Pages: 318

ISBN-13: 0309212421

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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.

Mechanical Circulatory Support: A Companion to Braunwald's Heart Disease Ebook
Mechanical Circulatory Support: A Companion to Braunwald's Heart Disease Ebook

Author: James K Kirklin

Publisher: Elsevier Health Sciences

Published: 2019-07-09

Total Pages: 324

ISBN-13: 0323566979

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Offering comprehensive, authoritative coverage of mechanical circulatory support (MCS), this fully revised companion to Braunwald's Heart Disease provides the clinically relevant information you need to effectively use this therapy to treat and manage end-stage heart failure. New editors and authors – experts in both cardiology and cardiovascular surgery – bring you fully up to date with the newest technology and devices, as well as basic science, clinical applications, adverse event monitoring and management, socioeconomic implications, future directions, and more. - Covers all of the newest techniques, including new-generation devices. - Discusses the management of common patient problems, highlighting cautions and outcomes, as well as pathophysiology and rationale for treatment. - Brings you up to speed with the latest coverage of ventricular assist devices (VAD), extracorporeal membrane oxygenation (ECMO), next-generation centrifugal pumps, and total artificial hearts. - Provides a complete clinical perspective of the latest scientific breakthroughs and analysis of the current literature. - Includes coverage of the most recent guidelines and protocols, including MCS for pediatric and congenital heart disease; the Interagency Registry of Mechanically Assisted Circulatory Support (INTERMACS) as a tool to track and advance clinical practice; and cellular, molecular, genomic, and functional changes that occur in the failing heart in response to MCS. - Presents practical evidence from the registry of thousands of cases to guide cardiologists, cardiovascular surgeons, emergency physicians, primary care physicians, and other team members on the best management course to follow for each particular patient. - Enhanced eBook version included with purchase, which allows you to access all of the text, figures, and references from the book on a variety of devices

Mastering and Managing the FDA Maze
Mastering and Managing the FDA Maze

Author: Gordon Harnack

Publisher: Quality Press

Published: 2014-07-18

Total Pages: 501

ISBN-13: 1636940463

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The number of FDA regulations and the agency’s increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firm’s employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions