An Act To Amend The Federal Food Drug And Cosmetic Act To Make Improvements In The Regulation Of Medical Devices And For Other Purposes PDF Download
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Author | : United States |
Publisher | : |
Total Pages | : 20 |
Release | : 1990 |
Genre | : Medical instruments and apparatus |
ISBN | : |
Download An Act to Amend the Federal Food, Drug, and Cosmetic Act to Make Improvements in the Regulation of Medical Devices, and for Other Purposes Book in PDF, ePub and Kindle
Author | : United States. Bureau of Medical Devices and Diagnostic Products |
Publisher | : |
Total Pages | : 40 |
Release | : 1975 |
Genre | : |
ISBN | : |
Download Pertinent Sections of the Federal Food, Drug, and Cosmetic Act as Amended and Code of Federal Regulations, Title 21 Relating to Devices Book in PDF, ePub and Kindle
Author | : United States |
Publisher | : |
Total Pages | : 156 |
Release | : 2007 |
Genre | : Drugs |
ISBN | : |
Download An Act to Amend the Federal Food, Drug, and Cosmetic Act to Revise and Extend the User-Fee Programs for Prescription Drugs and for Medical Devices, to Enhance the Postmarket Authorities of the Food and Drug Administration with Respect to the Safety of Drugs, and for Other Purposes Book in PDF, ePub and Kindle
Author | : United States |
Publisher | : |
Total Pages | : 45 |
Release | : 1976* |
Genre | : Medical instruments and apparatus |
ISBN | : |
Download An Act to Amend the Federal Food, Drug, and Cosmetic Act to Provide for the Safety and Effectiveness of Medical Devices Intended for Human Use, and for Other Purposes Book in PDF, ePub and Kindle
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 318 |
Release | : 2011-10-25 |
Genre | : Medical |
ISBN | : 0309212456 |
Download Medical Devices and the Public's Health Book in PDF, ePub and Kindle
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.
Author | : United States. Federal Trade Commission. Bureau of Consumer Protection |
Publisher | : |
Total Pages | : 32 |
Release | : 1998 |
Genre | : Advertising |
ISBN | : |
Download Dietary Supplements Book in PDF, ePub and Kindle
Author | : United States. Congress. House. Committee on Interstate and Foreign Commerce |
Publisher | : |
Total Pages | : 120 |
Release | : 1949 |
Genre | : Antibiotics |
ISBN | : |
Download To Amend the Federal Food, Drug, and Cosmetic Act Book in PDF, ePub and Kindle
Considers legislation to include certain new antibiotics in Federal drug safety inspection regulations; to require exported drugs, food, cosmetics and devices to comply with domestic product safety standards; and to authorize FDA to charge importers for costs incurred in supervising relabeling and other procedures necessary to bring imported articles into compliance with domestic standards.
Author | : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment |
Publisher | : |
Total Pages | : 334 |
Release | : 1991 |
Genre | : Health & Fitness |
ISBN | : |
Download Food, Drug, Cosmetic, and Device Enforcement Amendments Book in PDF, ePub and Kindle
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.
Author | : United States |
Publisher | : |
Total Pages | : 10 |
Release | : 1992 |
Genre | : Dietary supplements |
ISBN | : |
Download An Act to Amend the Federal Food, Drug, and Cosmetic Act to Authorize Human Drug Application, Prescription Drug Establishment, and Prescription Drug Product Fees and for Other Purposes Book in PDF, ePub and Kindle
Author | : United States. Department of Health, Education, and Welfare |
Publisher | : |
Total Pages | : 88 |
Release | : 1963 |
Genre | : Cosmetics |
ISBN | : |
Download Federal Food, Drug, and Cosmetic Act, as Amended and General Regulations for Its Enforcement, Title 21, Part 1 Book in PDF, ePub and Kindle