§ 870.2790. Photoplethysmograph analysis software for over-the-counter use.
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/us/cfr/t21/s§ 870.2790·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
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§ 870.2790
Photoplethysmograph analysis software for over-the-counter use.
Fed. Reg.×1
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