§870.2790. Photoplethysmograph analysis software for over-the-counter use.
21 C.F.R. § 870.2790
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.
Classification. Class II (special controls). The special controls for this device are:
Clinical performance testing must demonstrate the performance characteristics of the detection algorithm under anticipated conditions of use.
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.
Non-clinical performance testing must demonstrate the ability of the device to detect adequate photoplethysmograph signal quality.
Human factors and usability testing must demonstrate the following:
The user can correctly use the device based solely on reading the device labeling; and
The user can correctly interpret the device output and understand when to seek medical care.
Labeling must include:
Hardware platform and operating system requirements;
Situations in which the device may not operate at an expected performance level;
A summary of the clinical performance testing conducted with the device;
A description of what the device measures and outputs to the user; and
Guidance on interpretation of any results.
Notes, amendments, and revision history
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]