Section 870.2790 - Photoplethysmograph analysis software for over-the-counter use(a)Identification. A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. 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 must demonstrate the performance characteristics of the detection algorithm under anticipated conditions of use.(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 demonstrate the ability of the device to detect adequate photoplethysmograph signal quality.(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. 87 FR 6419 , Feb. 4, 2022