Section 870.2345 - Electrocardiograph software for over-the-counter use(a)Identification. An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.(b)Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing under anticipated conditions of use must demonstrate the following: (i) The ability to obtain an electrocardiograph of sufficient quality for display and analysis; and(ii) The performance characteristics of the detection algorithm as reported by sensitivity and either specificity or positive predictive value.(2) Software verification, validation, and hazard analysis must be performed. Documentation must include a characterization of the technical specifications of the software, including the detection algorithm and its inputs and outputs.(3) Non-clinical performance testing must validate detection algorithm performance using a previously adjudicated data set.(4) Human factors and usability testing must demonstrate the following:(i) The user can correctly use the device based solely on reading the device labeling; and(ii) The user can correctly interpret the device output and understand when to seek medical care.(5) Labeling must include:(i) Hardware platform and operating system requirements;(ii) Situations in which the device may not operate at an expected performance level;(iii) A summary of the clinical performance testing conducted with the device;(iv) A description of what the device measures and outputs to the user; and(v) Guidance on interpretation of any results. 86 FR 2549 , Jan. 18, 2022