Dear AuntMinnie Member,
As the debate over mammography guidelines rages, another breast imaging controversy is bubbling under the surface: the U.S. Food and Drug Administration's regulation of full-field digital mammography (FFDM) systems and computer-aided detection (CAD) software.
The agency originally proposed in 2006 that FFDM systems be regulated as class II devices rather than class III. The change would enable mammography vendors to bring the systems to market using the 510(k) process rather than the more burdensome premarket approval (PMA) route, according to an article by associate editor Kate Madden Yee in our Women's Imaging Digital Community.
Now, nearly four years later, the FDA is still talking rather than acting, and some mammography advocates believe the delay is limiting Americans' access to FFDM and CAD technologies already available in other countries. To learn more, click here.
Meanwhile, the mammography guidelines debate has evolved into a political football as Democrats and Republicans feud over healthcare reform. Read two articles offering analysis by clicking here and here, and be sure to check out several threads in our Forums dissecting what it all means.
Meeting to address MRI contrast
While we're on the subject of FDA regulation, the agency will host a meeting in December on its regulation of gadolinium-based MRI contrast agents, according to a story we're featuring in our MRI Digital Community.
The FDA in 2007 mandated a black box warning on all gadolinium-based contrast media due to reports of nephrogenic systemic fibrosis (NSF) in patients. But many questions remain, including whether NSF is related to a specific formulation of gadolinium or whether it's due to a class effect.
Features editor Wayne Forrest offers a preview of the meeting in an article you can read by clicking here. For additional coverage of this issue and other topics related to MRI, visit the community at mri.auntminnie.com.
