Medical Device Register
Medical Device Register

Author:

Publisher:

Published: 2007

Total Pages: 1692

ISBN-13:

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Contains a list of all manufacturers and other specified processors of medical devices registered with the Food and Drug Administration, and permitted to do business in the U.S., with addresses and telephone numbers. Organized by FDA medical device name, in alphabetical order. Keyword index to FDA established standard names of medical devices.

Public Health Effectiveness of the FDA 510(k) Clearance Process
Public Health Effectiveness of the FDA 510(k) Clearance Process

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2010-10-04

Total Pages: 141

ISBN-13: 0309162904

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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 Device Regulation
Medical Device Regulation

Author: Elijah Wreh

Publisher: Elsevier

Published: 2023-02-22

Total Pages: 680

ISBN-13: 0323953530

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Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification Puts regulations in the context of contemporary design Includes case studies and applications of regulations