FDA Wants To Reclassify Digital Mammograms

Law360, New York (May 30, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration is seeking to reclassify full-field digital mammography systems, a fairly new alternative to film mammograms, from Class III to Class II so that new devices no longer require premarket approval.

According to a notice published in the Federal Register, the FDA believes that the safety of the devices could be ensured by classifying them as Class II, or “special controls,” rather than subjecting each new mammography device to the approval process.

Under FDA regulation, to change the classification of the...
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