21 CFR §870.2790

1. (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.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)Clinical performance testing must demonstrate the performance characteristics of the detection algorithm under anticipated conditions of use.
   2. (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. (3)Non-clinical performance testing must demonstrate the ability of the device to detect adequate photoplethysmograph signal quality.
   4. (4)Human factors and usability testing must demonstrate the following:
      1. (i)The user can correctly use the device based solely on reading the device labeling; and
      2. (ii)The user can correctly interpret the device output and understand when to seek medical care.
   5. (5)Labeling must include:
      1. (i)Hardware platform and operating system requirements;
      2. (ii)Situations in which the device may not operate at an expected performance level;
      3. (iii)A summary of the clinical performance testing conducted with the device;
      4. (iv)A description of what the device measures and outputs to the user; and
      5. (v)Guidance on interpretation of any results.