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Diane Publishing Books
Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections: Congressional Testimony
Marcia Crosse (au)
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.
Rise of Life: The First 3.5 Billion Years
Customer Service Operations: The Complete Guide
Sagas of Icelanders: A Selection
Creole Flavors: Recipes for Marinades, Rubs, Sauces, & Spices
Woman’s Guide to Making Therapy Work
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