{"data":{"id":"us/21-cfr-882.5855","jurisdiction":"us","citation":"21 CFR 882.5855","heading":"Brain stimulation programming planning software.","body":"(a) Identification. The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.\n(b) Classification. Class II (special controls). The special controls for this device are:\n(1) Software verification, validation, and hazard analysis must be performed.\n(2) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.\n(3) Labeling must include:\n(i) The implanted brain stimulators for which the device is compatible.\n(ii) Instructions for use.\n(iii) Instructions and explanations of all user-interface components.\n(iv) A warning regarding use of the data with respect to not replacing clinical judgment.","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":"249210284fbc40830c828b1d267fb9433a29fd166e8d35e983d20d037f1dc7d6","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-882.5850","next":"us/21-cfr-882.5860"},"notice":"GroundRules: Original legal text. Not legal advice."}