Author: Daniel F. O'KeefePublisher:
ISBN:
Category : Law
Languages : en
Pages : 658
Book Description
An Analytical Legislative History of the Medical Device Amendments of 1976
Author: Daniel F. O'KeefePublisher:
ISBN:
Category : Law
Languages : en
Pages : 658
Book Description
Execution of Public Law 94-295
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Government publications
Languages : en
Pages : 32
Book Description
Medical Device Amendments of 1976, as Further Amended by the Safe Medical Devices Act of 1990
Author: Center for Devices and Radiological Health (U.S.)Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 40
Book Description
Public Health Effectiveness of the FDA 510(k) Clearance Process
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141
Book Description
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.
Medical Devices and the Public's Health
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309212456
Category : Medical
Languages : en
Pages : 318
Book Description
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 Device Regulation
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and InvestigationsPublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 82
Book Description
Federal Regulation of Medical Devices
Author: United States. General Accounting OfficePublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 96
Book Description
Execution of Public Law 94-295 (Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act)
Author: Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 30
Book Description
Legislative History of the Medical Devices Amendments of 1976
Author: Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages :
Book Description
Medical Device Amendments of 1976
Author: Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages :
Book Description