The U.S. Food and Drug Administration (FDA) has released a new draft guidance for display devices used in diagnostic radiology.
When finalized, the guidance will reflect the FDA's current thinking on PACS displays, which are classified as class II devices and intended for use in controlled viewing conditions to display and view digital images for primary interpretation, according to the FDA. In addition, it will supersede the FDA's 2008 guidance relating to display accessories for full-field digital mammography systems.
The draft guidance previews the FDA's recommendations for the type of information that should be included in 510(k) submissions for displays, such as indications for use, device description, electrical safety evaluation, firmware and software documentation, physical laboratory testing, and labeling information. The FDA also offers additional details on performance tests, device modifications, and device bundling.
The agency noted that the guidance does not apply to real-time displays that are part of image acquisition devices; medical image hardcopy devices; imaging software and software applications; ophthalmic image management systems; medical cathode-ray tube displays; displays intended for whole-slide imaging and digital surgical or anatomical pathology; or displays for nonradiological applications. What's more, it also does not apply to displays in handheld or mobile devices.
The draft guidance can be found here. The FDA is accepting comments for the next 90 days.
