eCFR Reference Browser

---

title: "21 CFR §882.1935"

source: "https://www.ecfr.gov/current/title-21/section-882.1935"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "882"

part_subject: "NEUROLOGICAL DEVICES"

subpart_code: "B"

subpart_subject: "Neurological Diagnostic Devices"

section_number: "882.1935"

section_subject: "Near Infrared (NIR) Brain Hematoma Detector."

cfr_reference: "21 CFR 882.1935"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§882.1935 - Near Infrared (NIR) Brain Hematoma Detector.