{"data":{"id":"us/21-cfr-882.1935","jurisdiction":"us","citation":"21 CFR 882.1935","heading":"Near Infrared (NIR) Brain Hematoma Detector.","body":"(a) Identification. A Near Infrared (NIR) Brain Hematoma Detector is a noninvasive device that employs near-infrared spectroscopy that is intended to be used to evaluate suspected brain hematomas.\n(b) Classification. Class II (special controls). The special controls for this device are:\n(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;\n(2) The labeling must include specific instructions and the clinical training needed for the safe use of this device;\n(3) Appropriate analysis/testing should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics;\n(4) Performance data should validate accuracy and precision and safety features;\n(5) Any elements of the device that may contact the patient should be demonstrated to be biocompatible; and,\n(6) Appropriate software verification, validation, and hazard analysis should be performed.","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 B—Neurological Diagnostic 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":"6da81bd8e4be8a6fcee2cc6c6ceb7cbb1e74aff37be74a76d78cb04016ab4039","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-882.1925","next":"us/21-cfr-882.1950"},"notice":"GroundRules: Original legal text. Not legal advice."}