21 CFR § 870.2790 - Photoplethysmograph analysis software for over-the-counter use.
---
identifier: "/us/cfr/t21/s870.2790"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 870.2790 - Photoplethysmograph analysis software for over-the-counter use."
title_number: 21
title_name: "Food and Drugs"
section_number: "870.2790"
section_name: "Photoplethysmograph analysis software for over-the-counter use."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "870"
part_name: "CARDIOVASCULAR DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 7907, Feb. 5, 1980, unless otherwise noted."
cfr_part: "870"
---
# 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]