---
kind: "section"
citation: "21 C.F.R. § 870.2786"
title: "21"
number: "870.2786"
heading: "Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate."
url: "https://uscodex.org/cfr/21/870.2786"
---

# §870.2786. Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.

- (a) **Identification.** The device uses an optical sensor system and software algorithms to obtain and analyze video signal and estimate pulse rate, heart rate, breathing rate, and/or respiratory rates. This device is not intended to independently direct therapy.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must include:
    - (i) A full characterization of the software technical parameters, including algorithms;
    - (ii) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy; and
    - (iii) Software documentation must include a cybersecurity vulnerability and management process to assure software functionality.
  - (2) Performance testing must demonstrate the safety of any illuminating optics.
  - (3) Clinical data must be provided. This assessment must fulfill the following:
    - (i) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified.
    - (ii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment.
    - (iii) The assessment must compare device output with a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner.
  - (4) A human factors and usability engineering assessment must be provided that evaluates the risk of improper measurement.
  - (5) Labeling must include:
    - (i) A description of what the device measures and outputs to the user;
    - (ii) Warnings identifying sensor acquisition factors or subject conditions or characteristics (garment types/textures, motion, etc.) that may impact measurement results;
    - (iii) Guidance for interpretation of the measurements, including a statement that the output is adjunctive to other physical vital sign parameters and patient information;
    - (iv) The expected performance of the device for all intended use populations and environments; and
    - (v) **Robust instructions to ensure correct system setup.**

## Notes

### Amendments

[88 FR 976, Jan. 6, 2023]

### 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

[88 FR 976, Jan. 6, 2023]