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Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections: Congressional Testimony
As part of the FDA’s oversight of the safety & eff

Our Price: $15.00
By Marcia Crosse (au)
Year: 2008
Pages: 26
Binding Paperback

Product Code: 1437900208

As part of the FDAs 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 FDAs mgmt. of inspections of establishments -- particularly those in foreign countries -- manufacturing devices for the U.S. market; & (2) provides the status of FDAs programs for third-party inspections of medical device manufacturing establishments. Illustrations.

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