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

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.