Radiation-Emitting Products

Is Full Field Digital Mammography (FFDM) considered a mammographic modality?

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Yes. FFDM is a technology for radiography of the breast and, therefore, is a mammographic modality. Until January 2000, FFDM was classified as an investigational use of mammography and thus was exempted from the MQSA requirements. 21 C.F.R. 900.2(aa)(2). However, FFDM units produced by a growing number of manufacturers have since been approved by FDA for commercial distribution. Such approved units are subject to the MQSA requirements. However, those FFDM units that are not yet cleared for commercial distribution are still viewed as investigational units and continue to be exempt from the MQSA requirements.

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Page Last Updated: 07/25/2014
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