---
kind: "section"
citation: "21 C.F.R. § 870.2790"
title: "21"
number: "870.2790"
heading: "Photoplethysmograph analysis software for over-the-counter use."
url: "https://uscodex.org/cfr/21/870.2790"
---

# §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.**

## Notes

### Amendments

[87 FR 6419, Feb. 4, 2022]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

### Amendments

[87 FR 6419, Feb. 4, 2022]