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Author: Marcia Crosse Publisher: DIANE Publishing ISBN: 1437900208 Category : Business & Economics Languages : en Pages : 30
Book Description
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: Marcia Crosse Publisher: DIANE Publishing ISBN: 1437900208 Category : Business & Economics Languages : en Pages : 30
Book Description
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 Government Accountability Office Publisher: Createspace Independent Publishing Platform ISBN: 9781983857881 Category : Languages : en Pages : 30
Book Description
Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections
Author: Marcia Crosse Publisher: DIANE Publishing ISBN: 1437905277 Category : Health & Fitness Languages : en Pages : 26
Book Description
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: United States Government Accountability Office Publisher: Createspace Independent Publishing Platform ISBN: 9781983848940 Category : Languages : en Pages : 26
Book Description
Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments
Author: U S Government Accountability Office (G Publisher: BiblioGov ISBN: 9781289258986 Category : Languages : en Pages : 30
Book Description
The U.S. Government Accountability Office (GAO) is an independent agency that works for Congress. The GAO watches over Congress, and investigates how the federal government spends taxpayers dollars. The Comptroller General of the United States is the leader of the GAO, and is appointed to a 15-year term by the U.S. President. The GAO wants to support Congress, while at the same time doing right by the citizens of the United States. They audit, investigate, perform analyses, issue legal decisions and report anything that the government is doing. This is one of their reports.
Author: Marcia Crosse Publisher: DIANE Publishing ISBN: 1437918212 Category : Health & Fitness Languages : en Pages : 22
Book Description
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: Marcia Crosse
Author: Marcia Crosse
Author: United States Government Accountability Office
Author: Marcia Crosse
Author: 
Author: Marcia Crosse
Author: Marcia Crosse
Author: United States Government Accountability Office
Author: U S Government Accountability Office (G
Author: Marcia Crosse
Author: Marcia Crosse