Medical Devices and the Public s Health is popular PDF and ePub book, written by Institute of Medicine in 2011-10-25, it is a fantastic choice for those who relish reading online the Medical genre. Let's immerse ourselves in this engaging Medical book by exploring the summary and details provided below. Remember, Medical Devices and the Public s Health can be Read Online from any device for your convenience.
Medical Devices and the Public s Health Book PDF Summary
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.
Detail Book of Medical Devices and the Public s Health PDF
- Author : Institute of Medicine
- Release : 25 October 2011
- Publisher : National Academies Press
- ISBN : 9780309212458
- Genre : Medical
- Total Page : 318 pages
- Language : English
- PDF File Size : 10,7 Mb
If you're still pondering over how to secure a PDF or EPUB version of the book Medical Devices and the Public s Health by Institute of Medicine, don't worry! All you have to do is click the 'Get Book' buttons below to kick off your Download or Read Online journey. Just a friendly reminder: we don't upload or host the files ourselves.