Medical Devices and the Public's Health

Medical Devices and the Public's Health
Author :
Publisher : National Academies Press
Total Pages : 318
Release :
ISBN-10 : 9780309212427
ISBN-13 : 0309212421
Rating : 4/5 (421 Downloads)

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 2011-11-25 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.


Medical Devices and the Public's Health Related Books

Class 1 Devices
Language: en
Pages: 115
Authors: Peter J. Ogrodnik
Categories: Technology & Engineering
Type: BOOK - Published: 2014-11-24 - Publisher: Academic Press

GET EBOOK

The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles comple
Medical Devices and the Public's Health
Language: en
Pages: 318
Authors: Institute of Medicine
Categories: Medical
Type: BOOK - Published: 2011-11-25 - Publisher: National Academies Press

GET EBOOK

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
Inspection of Medical Devices
Language: en
Pages: 285
Authors: Almir Badnjević
Categories: Technology & Engineering
Type: BOOK - Published: 2017-10-26 - Publisher: Springer

GET EBOOK

This book offers all countries a guide to implementing verification systems for medical devices to ensure they satisfy their regulations. It describes the proce
Medical Device Design
Language: en
Pages: 369
Authors:
Categories: Technology & Engineering
Type: BOOK - Published: 2012-12-17 - Publisher: Academic Press

GET EBOOK

This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a
Innovation and Protection
Language: en
Pages: 295
Authors: I. Glenn Cohen
Categories: Law
Type: BOOK - Published: 2022-04-07 - Publisher: Cambridge University Press

GET EBOOK

A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.