{"data":{"id":"us/21-cfr-882.5804","jurisdiction":"us","citation":"21 CFR 882.5804","heading":"Computerized behavioral therapy device for the treatment of fibromyalgia symptoms.","body":"(a) Identification. A computerized behavioral therapy device for the treatment of fibromyalgia symptoms is a prescription device intended to provide a computerized version of behavioral therapy for the treatment of fibromyalgia symptoms.\n(b) Classification. Class II (special controls). The special controls for this device are:\n(1) Clinical data must demonstrate that the device performs as intended under the anticipated conditions of use and include the following:\n(i) Evaluation of improvement in the symptoms of fibromyalgia; and\n(ii) Evaluation of relevant adverse events.\n(2) Software verification, validation, and hazard analysis must demonstrate that the device performs as intended.\n(3) Physician and patient labeling must include the following:\n(i) Recommended treatment regimes, including frequency and duration of use; and\n(ii) A summary of the clinical data for the device, including a discussion of adverse events.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 882—NEUROLOGICAL DEVICES","Subpart F—Neurological Therapeutic 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":"7efbad403c052cba2746fc35b230664724ebf2b52097a83670558511c6fdbb02","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-882.5803","next":"us/21-cfr-882.5805"},"notice":"GroundRules: Original legal text. Not legal advice."}