{"data":{"id":"us/21-cfr-870.2790","jurisdiction":"us","citation":"21 CFR 870.2790","heading":"Photoplethysmograph analysis software for over-the-counter use.","body":"(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.\n(b) Classification. Class II (special controls). The special controls for this device are:\n(1) Clinical performance testing must demonstrate the performance characteristics of the detection algorithm under anticipated conditions of use.\n(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.\n(3) Non-clinical performance testing must demonstrate the ability of the device to detect adequate photoplethysmograph signal quality.\n(4) Human factors and usability testing must demonstrate the following:\n(i) The user can correctly use the device based solely on reading the device labeling; and\n(ii) The user can correctly interpret the device output and understand when to seek medical care.\n(5) Labeling must include:\n(i) Hardware platform and operating system requirements;\n(ii) Situations in which the device may not operate at an expected performance level;\n(iii) A summary of the clinical performance testing conducted with the device;\n(iv) A description of what the device measures and outputs to the user; and\n(v) Guidance on interpretation of any results.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 870—CARDIOVASCULAR DEVICES","Subpart C—Cardiovascular Monitoring Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"374030d5cb8d37ef241cbf26b948056a829b00053f9064fa2de93a960d1a9b63","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-870.2786","next":"us/21-cfr-870.2800"},"notice":"GroundRules: Original legal text. Not legal advice."}