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Digital Mammography 510(k) Status Recommended By FDA Panel

This article was originally published in The Gray Sheet

Executive Summary

Full-field digital mammography systems should be downclassified to Class II, supported by revised guidance as a special control, FDA's Radiological Devices Advisory Panel recommended May 23

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Digital Mammography Systems Are Now 510(k) Products – FDA Final Rule

Two-dimensional digital mammography systems, such as those made by Hologic and GE Healthcare, can now enter the market through the 510(k) versus PMA route, according to a final rule and special controls guidance issued Nov. 4.

Digital Mammography Systems Are Now 510(k) Products – FDA Final Rule

Two-dimensional digital mammography systems, such as those made by Hologic and GE Healthcare, can now enter the market through the 510(k) versus PMA route, according to a final rule and special controls guidance issued Nov. 4.

FDA Reclassifications In Brief

Digital mammography: FDA 1proposes May 30 to downclassify full field digital mammography systems from Class III to Class II, following the 2006 recommendation of its Radiological Devices Panel (2"The Gray Sheet" May 29, 2006, p. 6). The agency also released a special controls 3draft guidance outlining proposed electrical safety and physical laboratory 510(k) testing requirements. Comments on the proposed reclassification and draft guidance are due Aug. 29

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