WASHINGTON (CN) – The FDA will leave it up to manufacturers to ensure that certain mammography units are up to snuff.
The particular unit involved produces planar digital x-ray images of the entire breast. The related items also swept up in the Food and Drug Administration’s rule include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts and accessories.
The manufacturers are to follow procedures in an FDA document before marketing the items to the public.
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