DPA Recommends Whole Slide Imaging Manufacturers Submit De Novo Applications to the FDA for Primary Diagnosis in the United States

The Digital Pathology Association (DPA) announced today that it suggests digital pathology manufacturers currently interested in marketing whole slide imaging (WSI) devices for primary diagnosis in the United States submit de novo applications to the Food and Drug Administration (FDA). WSI is a technology which allows glass slides to be reviewed digitally, rather than by a microscope, offering many potential advantages over conventional methodologies. Digital pathology devices are currently not approved for primary diagnostic use in the United States. Until now, the DPA has suggested that manufacturers of WSI devices intended for primary diagnosis plan to submit premarket applications (PMAs). PMAs are required to be approved by the FDA prior to marketing a Class III medical device. Class III is the highest risk classification for medical devices; Class II devices are considered moderate risk and Class I are low risk.


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Published in: Press Releases  on Thursday 14th of January 2016