Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments
Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments

Author: Marcia Crosse

Publisher: DIANE Publishing

Published: 2008-12

Total Pages: 26

ISBN-13: 1437905277

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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.

Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections
Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections

Author: Marcia Crosse

Publisher: DIANE Publishing

Published: 2008-05

Total Pages: 30

ISBN-13: 1437900208

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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.

Medical Devices: Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments
Medical Devices: Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments

Author: Marcia Crosse

Publisher: DIANE Publishing

Published: 2010-05

Total Pages: 22

ISBN-13: 1437918212

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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.

Medical Devices
Medical Devices

Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health

Publisher:

Published: 2012

Total Pages: 112

ISBN-13:

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