Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments PDF Download
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Author: Marcia Crosse
Publisher: DIANE Publishing
ISBN: 1437905277
Category : Health & Fitness
Languages : en
Pages : 26
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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: Marcia Crosse
Publisher: DIANE Publishing
ISBN: 1437905277
Category : Health & Fitness
Languages : en
Pages : 26
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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
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Book Description
Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments
Author: Marcia Crosse
Publisher: DIANE Publishing
ISBN: 1437900208
Category : Business & Economics
Languages : en
Pages : 30
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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:
ISBN:
Category :
Languages : en
Pages : 26
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Book Description
Author: Marcia Crosse
Publisher:
ISBN:
Category :
Languages : en
Pages : 0
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Book Description
Author: Marcia Crosse
Publisher: DIANE Publishing
ISBN: 1437918212
Category : Health & Fitness
Languages : en
Pages : 22
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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:
Publisher: DIANE Publishing
ISBN: 1437941745
Category :
Languages : en
Pages : 43
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Book Description
Author: Food and Drug Administration
Publisher:
ISBN: 9780865879737
Category : Drugs
Languages : en
Pages : 0
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Book Description
Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
ISBN:
Category : Cosmetics
Languages : en
Pages : 240
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Book Description
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 268
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Book Description
