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Author : United States Government Accountability Office
Publisher : Createspace Independent Publishing Platform
Page : 26 pages
File Size : 48,8 Mb
Release : 2018-01-14
Category : Electronic
ISBN : 1983848948
Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments
Author : Marcia Crosse
Publisher : DIANE Publishing
Page : 26 pages
File Size : 51,7 Mb
Release : 2008-12
Category : Health & Fitness
ISBN : 9781437905274
As part of the FDA oversight of the safety and effectiveness of medical devices marketed in the U.S., it inspects certain foreign and domestic establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee and Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two voluntary programs for that purpose. This statement assesses: (1) FDA¿s program for inspecting foreign establishments that manufacture medical devices for the U.S. market; and (2) FDA¿s programs for third-party inspections of those establishments.
Author : Marcia Crosse,United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations,United States. Government Accountability Office
Publisher : Unknown
Page : 26 pages
File Size : 54,7 Mb
Release : 2008
Category : Electronic
ISBN : OCLC:406819530
Author : Marcia Crosse
Publisher : Unknown
Page : 0 pages
File Size : 47,5 Mb
Release : 2008
Category : Electronic
ISBN : OCLC:232614345
Author : Marcia Crosse
Publisher : DIANE Publishing
Page : 30 pages
File Size : 53,8 Mb
Release : 2008-05
Category : Business & Economics
ISBN : 9781437900200
As part of the FDA¿s oversight of the safety & effectiveness of medical devices marketed in the U.S., it inspects domestic & foreign establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee & Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two such voluntary programs. This statement: (1) assesses FDA¿s mgmt. of inspections of establishments -- particularly those in foreign countries -- manufacturing devices for the U.S. market; & (2) provides the status of FDA¿s programs for third-party inspections of medical device manufacturing establishments. Illustrations.
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher : Unknown
Page : 268 pages
File Size : 47,7 Mb
Release : 2008
Category : Business & Economics
ISBN : UOM:39015085459595
Author : Anonim
Publisher : Unknown
Page : 248 pages
File Size : 47,5 Mb
Release : 2010
Category : Electronic
ISBN : MINN:31951D03140315B
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Page : 240 pages
File Size : 55,7 Mb
Release : 2008
Category : Cosmetics
ISBN : UOM:39015085459587
Author : Marcia Crosse
Publisher : DIANE Publishing
Page : 22 pages
File Size : 52,6 Mb
Release : 2010-05
Category : Health & Fitness
ISBN : 9781437918212
Americans depend on FDA to provide assurance that medical devices (MD) sold in the U.S. are safe and effective. FDA classifies MD types into 3 classes, with class I: those with the lowest risk to patients (such as forceps) and class III: those with the greatest risk (such as pacemakers). FDA's responsibilities include premarket and postmarket oversight -- spanning, for ex., both premarket review of MD and postmarket surveillance. These responsibilities apply to all devices marketed in the U.S., regardless of whether they are manufactured domestically or overseas. This testimony relates to FDA's responsibilities for MD, including premarket review, postmarket surveillance, and inspection of manufacturing establishments.
Author : Anonim
Publisher : DIANE Publishing
Page : 43 pages
File Size : 52,8 Mb
Release : 2024-07-01
Category : Electronic
ISBN : 9781437941746
Author : Marcia Crosse
Publisher : DIANE Publishing
Page : 81 pages
File Size : 50,5 Mb
Release : 2010
Category : Medical
ISBN : 9781437920703
Twenty years ago, it was reported that the FDA was concerned that it lacked resources to fulfill its mission, which includes oversight of the safety and effectiveness of medical products -- human drugs, biologics, and medical devices -- marketed for sale in the U.S. Since then, concerns have been raised regarding FDA's ability to meet its oversight responsibilities. This report reviews the resources supporting FDA's medical product oversight responsibilities. It examines trends in: (1) FDA's funding and staffing resources for its medical product oversight responsibilities from FY 1999 through 2008; and (2) FDA's medical product oversight responsibilities during this same period. Charts and tables.
Author : Marcia Crosse
Publisher : DIANE Publishing
Page : 58 pages
File Size : 48,6 Mb
Release : 2009-05
Category : Technology & Engineering
ISBN : 9781437911305
The FDA oversees the safety and effectiveness of human drugs marketed in the U.S., including those manufactured in foreign establishments. FDA inspects foreign establishments in order to ensure that the quality of drugs is not jeopardized by poor manufacturing processes. This report examines: (1) the extent to which FDA has accurate data on the number of foreign establishments subject to inspection; (2) the frequency of foreign inspections; and (3) oversight by FDA to ensure that foreign establishments correct serious problems identified during inspections. The author analyzed info. from FDA databases, reviewed inspection reports which identified serious deficiencies, and interviewed FDA officials. Includes recommendations. Illus.
Author : Valerie C. Melvin
Publisher : DIANE Publishing
Page : 57 pages
File Size : 52,9 Mb
Release : 2009-11
Category : Computers
ISBN : 9781437917376
The FDA relies heavily on info. tech. (IT) to carry out its responsibility for ensuring the safety and effectiveness of certain consumer products. Recognizing limitations in its IT capabilities that had been previously identified, the agency has begun various initiatives to modernize its IT systems. This report: (1) evaluates the FDA¿s overall plans for modernizing its IT systems, including the extent to which the plans address identified limitations or inadequacies in the agency¿s capabilities; and (2) assesses to what extent the agency has put in place key IT mgmt. policies and processes to guide the implementation of its modernization projects. Includes recommendations. Charts and tables.
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher : Unknown
Page : 112 pages
File Size : 46,8 Mb
Release : 2012
Category : Medical instruments and apparatus
ISBN : MINN:31951D034792315
Author : Lisa Shames
Publisher : DIANE Publishing
Page : 81 pages
File Size : 41,5 Mb
Release : 2009-06
Category : Health & Fitness
ISBN : 9781437911251
Two thirds of U.S. adults are overweight, and childhood obesity and diabetes are on the rise. To reverse these health problems, experts are urging Americans to eat healthier. Food labels contain information to help consumers who want to make healthy food choices. The FDA oversees fed. labeling rules for 80 percent of foods. This report examines: (1) FDA's efforts to ensure that domestic and imported foods comply with labeling rules; (2) the challenges FDA faces in these efforts; and (3) the views of key stakeholders on FDA actions needed to mitigate misleading labeling. The auditor analyzed FDA data, reports, and requirements on food labeling oversight and compliance and interviewed agency and key stakeholder group officials. Illus.