{"data":{"id":"us/21-cfr-870.2345","jurisdiction":"us","citation":"21 CFR 870.2345","heading":"Electrocardiograph software for over-the-counter use.","body":"(a) Identification. An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data and can provide information for identifying cardiac arrhythmias. 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 under anticipated conditions of use must demonstrate the following:\n(i) The ability to obtain an electrocardiograph of sufficient quality for display and analysis; and\n(ii) The performance characteristics of the detection algorithm as reported by sensitivity and either specificity or positive predictive value.\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 validate detection algorithm performance using a previously adjudicated data set.\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":"e9a68e7a7e161eb6b669c54fe541e879d270e50cadb3871de32223e5893890b3","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-870.2340","next":"us/21-cfr-870.2350"},"notice":"GroundRules: Original legal text. Not legal advice."}