21 CFR §870.2345

1. (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.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)Clinical performance testing under anticipated conditions of use must demonstrate the following:
      1. (i)The ability to obtain an electrocardiograph of sufficient quality for display and analysis; and
      2. (ii)The performance characteristics of the detection algorithm as reported by sensitivity and either specificity or positive predictive value.
   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 validate detection algorithm performance using a previously adjudicated data set.
   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.