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
Legislative History of the Medical Devices Amendments of 1976
Author: Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages :
Book Description
Medical Devices Amendments of 1976
Author: United States. CongressPublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages :
Book Description
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.
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.
Public Accountability and Medical Device Regulation
Author: Robert B LeflarPublisher:
ISBN:
Category :
Languages : en
Pages : 0
Book Description
In enacting the Medical Device Amendments of 1976, Congress instituted a flexible system of regulatory controls over a vast array of health care products. Analyzing the complex statute and its legislative history, Professor Leflar finds at the law's core a structure designed to ensure the Food and Drug Administration's accountability to the public for its regulatory actions. Reviewing the history of FDA's implementation of the medical device law, however, the author demonstrates that FDA has strayed widely and, he contends, illegally from the congressionally mandated structure of public accountability. In particular, in its review of new-model medical devices in the most risk-laden class, the agency has channeled the great majority of such devices into a clearance process of its own invention. This black-box "premarket notification" process circumvents statutory requirements of public advisory committee review in open meetings, published summaries of new products' safety and effectiveness data, and justification of marketing decisions -- effectively insulating those decisions from administrative and judicial review and from adequate congressional and public oversight. Professor Leflar recognizes that the medical device law is in some respects unworkable, that FDA's departure from the congressional design has been on the whole a well-intentioned effort to increase administrative efficiency, and that the agency has undertaken noteworthy internal reforms in response to public and congressional criticism. Nevertheless, FDA's device review process departs from democratic principles. To enhance FDA's administration of the law while preserving the principle of public accountability, the author offers a number of suggestions for statutory reform.
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 : 88
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
Federal Regulation of Medical Devices
Author: United States. General Accounting OfficePublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 96
Book Description
The Medical Device Industry
Author: Norman F. EstrinPublisher: CRC Press
ISBN: 9780824782689
Category : Medical
Languages : en
Pages : 1020
Book Description
Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach