FDA Outlines Approval Process For Medical Detection Systems

Law360, New York (July 3, 2012, 2:41 PM EDT) -- The U.S. Food and Drug Administration on Tuesday detailed how manufacturers can seek approval of specialized devices that doctors use to spot abnormalities in images produced during X-rays, CT scans and other procedures.

The guidance relates to so-called computer-assisted detection systems, or CADe, that can call attention to unusual findings when patients undergo radiological tests. Agency officials said the instructions have been in the works for more than four years and have experienced large-scale revisions in response to industry concern.

In a pair of guidance documents,...
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