Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections

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.