Requires testing that demonstrates photoplethysmograph analysis software is accurate and adequate for detecting irregular heart rhythms.
Requires manufacturers of photoplethysmograph analysis software to conduct clinical performance testing that reveals the performance characteristics of the detection algorithms under anticipated use cases.
Requires manufactures to perform verification, validation, and hazard analysis of the software, as well as divulge the software's technical specs including the detection algorithm and its inputs and outputs.
Key facts
🏛️ This document has been enacted by the U.S. Food and Drug Administration.
For authoritative text and metadata, visit the official source.
🎯 This document primarily applies to the private sector, rather than the government.
📜 This document's name is 21 CFR § 870.2790 ("Photoplethysmograph analysis software for over-the-counter use").
Themes AI risks, applications, governance strategies, and other themes addressed in AGORA documents.
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archived and reformatted in plaintext for AGORA. Footnotes, tables, and
similar material may be omitted. For the official text, visit the original source.
§ 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.
Identifies irregular heart rhythms using photoplethysmograph data without providing a diagnosis.
Identifies irregular heart rhythms using photoplethysmograph data without providing 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.
Classifies devices as Class II, requiring clinical testing, software validation, and non-clinical testing.
Classifies devices as Class II, requiring clinical testing, software validation, and non-clinical testing.
(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.
Requires demonstration of correct device use and interpretation; mandates specific labeling including performance and guidance.
Requires demonstration of correct device use and interpretation; mandates specific labeling including performance and guidance.