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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.
Book Synopsis Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments by : Marcia Crosse
Download or read book Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments written by Marcia Crosse and published by DIANE Publishing. This book was released on 2008-12 with total page 26 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments
Book Synopsis Medical Devices by : United States Government Accountability Office
Download or read book Medical Devices written by United States Government Accountability Office and published by Createspace Independent Publishing Platform. This book was released on 2018-01-14 with total page 26 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments
Download or read book Medical Devices written by Marcia Crosse and published by . This book was released on 2008 with total page 26 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Medical Devices written by Marcia Crosse and published by . This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
Book Synopsis Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections by : Marcia Crosse
Download or read book Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections written by Marcia Crosse and published by DIANE Publishing. This book was released on 2008-05 with total page 30 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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.
Book Synopsis Medical Devices: Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments by : Marcia Crosse
Download or read book Medical Devices: Shortcomings in FDA's Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments written by Marcia Crosse and published by DIANE Publishing. This book was released on 2010-05 with total page 22 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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.
Book Synopsis Food and Drug Administration by : Marcia Crosse
Download or read book Food and Drug Administration written by Marcia Crosse and published by DIANE Publishing. This book was released on 2010 with total page 81 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis FDA's Foreign Drug Inspection Program by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Download or read book FDA's Foreign Drug Inspection Program written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations and published by . This book was released on 2008 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Discussion Draft of the Food and Drug Administration Globalization Act Legislation: Device and Cosmetic Safety Provisions, Serial No. 110-117, May 14, 2008, 110-2 Hearing, * by :
Download or read book Discussion Draft of the Food and Drug Administration Globalization Act Legislation: Device and Cosmetic Safety Provisions, Serial No. 110-117, May 14, 2008, 110-2 Hearing, * written by and published by . This book was released on 2010 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Discussion Draft of the Food and Drug Administration Globalization Act Legislation by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book Discussion Draft of the Food and Drug Administration Globalization Act Legislation written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2008 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt:
