Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Government publications
Languages : en
Pages : 32
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
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
Execution of Public Law 94-295
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 0
Book Description
Public Law 94-295
Author: United StatesPublisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 45
Book Description
Food, Drug, Cosmetic, and Device Enforcement Amendments
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the EnvironmentPublisher:
ISBN:
Category : Health & Fitness
Languages : en
Pages : 312
Book Description
Abstract: This House hearing examines the additional enforcement needed for the requirements of the Federal Food, Drug, and Cosmetic Act. The bill would give the FDA the ability to recall defective and unsafe products, to assess civil penalties, to subpoena witnesses and documents to embargo defective products, and to destroy imported products that pose a danger to public health.
A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments
Author: Federal Food, Drug, and Cosmetic Act with Amendments
Author: United StatesMedical 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.
Publication Catalog of the U.S. Department of Health and Human Services
Author: United States. Department of Health and Human ServicesPublisher:
ISBN:
Category : Government publications
Languages : en
Pages : 516
Book Description
Publication Catalog of the U. S. Department of Health, Education and Welfare
Author: United States. Dept. of Health, Education, and WelfarePublisher:
ISBN:
Category : Government publications
Languages : en
Pages : 518
Book Description