Paving the way for product authorization: FDA proposes rule to reclassify medical image analyzers

On June 4, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed order to reclassify certain software that analyzes medical imaging from class III (premarket approval) devices to class II (subject to 510(k) premarket notification). Specifically, FDA is considering the classification of software used to analyze mammography, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries. This proposal comes at the Agency's own initiative and potentially affects a wide swath of future image analysis products. If finalized, manufacturers of the specific medical image analyzers will no longer have to submit a Premarket Approval (PMA), but will instead submit a 510(k) to the Agency if there is an appropriate predicate device.

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