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Code of Federal Regulations Title 21. Food and Drugs § 21.882.1935 Near Infrared (NIR) Brain Hematoma Detector

Current as of January 02, 2025 | Updated by Findlaw Staff

(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.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;

(2) The labeling must include specific instructions and the clinical training needed for the safe use of this device;

(3) Appropriate analysis/testing should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics;

(4) Performance data should validate accuracy and precision and safety features;

(5) Any elements of the device that may contact the patient should be demonstrated to be biocompatible;  and,

(6) Appropriate software verification, validation, and hazard analysis should be performed.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.882.1935 Near Infrared (NIR) Brain Hematoma Detector - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-882-1935/

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