The Radiological Devices Panel met on May 23, 2006, to discuss and vote on an FDA-initiated proposal to reclassify full-field digital mammography systems (FFDMs). Digital mammography systems are used for the screening of breast cancer and have been Class III devices which were subject to review by the Agency through the Premarket Application process. Since the technology of FFDMs is well established and Special Controls are readily available, the Agency sought input from the Panel to consider FFDMs as Class II devices which are reviewed through the Premarket Notification process. The Agency has prepared two guidances describing the required information to be contained in a Premarket Notification for FFDMs and its accessories.
Following a discussion of the risks, mitigations, and Special Controls associated with FFDMs, the Panel's recommendation was "approval" with a vote of: 7 For, 0 Against and 0 Abstentions.
The Panel membership for this meeting consisted of three mammographers, an imaging scientist, a medical physicist, a radiation oncologist, a statistician, a consumer representative, and an industry representative.
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