US FDA simplifies approval process for digital mammography devices
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration is downgrading the risk classification of full field digital mammography (FFDM) systems to Class II (medium-risk) devices with special controls, when such devices are intended to produce planar digital x-ray images of the entire breast1,2. This change should expedite the approval process for these products and ease the pathway to market, the agency says.
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