Medical Devices and the Public's Health
Medical Devices and the Public's Health

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-10-25

Total Pages: 318

ISBN-13: 0309212456

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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.

Student Assistance General Provisions, Federal Perkins Loan Program, Federal Family Education Loan Program (Us Department of Education Regulation) (Ed) (2018 Edition)
Student Assistance General Provisions, Federal Perkins Loan Program, Federal Family Education Loan Program (Us Department of Education Regulation) (Ed) (2018 Edition)

Author: The Law The Law Library

Publisher: Createspace Independent Publishing Platform

Published: 2018-07-22

Total Pages: 178

ISBN-13: 9781723575242

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Student Assistance General Provisions, Federal Perkins Loan Program, Federal Family Education Loan Program (US Department of Education Regulation) (ED) (2018 Edition) The Law Library presents the complete text of the Student Assistance General Provisions, Federal Perkins Loan Program, Federal Family Education Loan Program (US Department of Education Regulation) (ED) (2018 Edition). Updated as of May 29, 2018 The Secretary amends the Student Assistance General Provisions, Federal Perkins Loan (Perkins Loan) Program, Federal Family Education Loan (FFEL) Program, and William D. Ford Federal Direct Loan (Direct Loan) Program regulations. These final regulations will: Amend the FFEL and Direct Loan program regulations to reflect changes made to the Higher Education Act of 1965, as amended (HEA), by the SAFRA Act included in the Health Care and Education Reconciliation Act of 2010; incorporate statutory changes to interest rates and other recent statutory changes in the Direct Loan Program regulations; update, strengthen, and clarify various areas of the Student Assistance General Provisions, Perkins Loan, FFEL, and Direct Loan program regulations; and provide for greater consistency in the regulations governing the title IV, HEA student loan programs. These final regulations will ensure that the title IV, HEA Federal student aid programs operate as efficiently as possible. This book contains: - The complete text of the Student Assistance General Provisions, Federal Perkins Loan Program, Federal Family Education Loan Program (US Department of Education Regulation) (ED) (2018 Edition) - A table of contents with the page number of each section

Current Catalog
Current Catalog

Author: National Library of Medicine (U.S.)

Publisher:

Published: 1979

Total Pages:

ISBN-13:

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First multi-year cumulation covers six years: 1965-70.