Medical device
Medical devices are classified and these classifications became somewhat less restrictive in December, 2010. Regulations provide rules for classifying medical devices into four increasing risk levels – Class I, Class II, Class III, and Class IV. Patient management software is classified as either Class I or Class II. Software that is intended to be used to view images, or other real time data, as an adjunct to the monitoring device itself, for the purpose of aiding in treatment or diagnosis of a patient, would be Class I medical devices. Medical device software that is an adjunct to another medical device and is involved in data manipulation, data analysis, data editing, image generation, determination of measurements, identification of a region of interest in an image, or identification (by an alarm or alert) of results from a monitor that are outside of an established range, is a Class II medical device if it: (1) provides the only means and opportunity to capture or acquire data from a medical device for aiding directly in diagnosis or treatment of a patient; or (2) replaces a diagnostic or treatment decision made by a physician.