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FDA Warns Mammographers About Records, Training.

Women's Health Weekly

| April 19, 2001 | COPYRIGHT 2001 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2001 APR 19 - (NewsRx.com & NewsRx.net) -- Almost 34% of the warning letters issued by the U.S. Food and Drug Administration (FDA) in January and February 2001 involved serious regulatory compliance problems with mammography standards, according to a review by NetCompliance, Inc., of the agency's currently available electronic Freedom Of Information Act (FOIA) data.

Of the 84 warning letters listed by the FDA for February 2001, 29 warned of compliance problems with mammography operations, ranging from missing records to lack of educational experience by the interpreting physician. According to FDA's listing for January 2001, 34 of 102 FDA warning letters dealt ...

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