Mammography standards compliance draws FDA's ire

AuntMinnie.com staff writers

Mar 26, 2001

Ensuring compliance with mammography standards apparently takes up a big chunk of the Food and Drug Administration's time. In January and February, nearly 34% of the warning letters issued by the FDA involved "serious" regulatory compliance problems with mammography standards, according to a review by regulatory compliance firm NetCompliance of Washington, DC.

Of the 84 warning letters the FDA listed today for February, 29 warned of operations compliance problems ranging from missing records to a lack of educational experience by the interpreting physician. In January, 34 of 102 FDA warning letters dealt with mammography compliance problems, according to NetCompliance.

By AuntMinnie.com staff writers
March 27, 2001
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Copyright © 2001 AuntMinnie.com

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