21 CFR 882.1935 - Near Infrared (NIR) Brain Hematoma Detector.

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There are 2 Updates appearing in the Federal Register for 21 CFR 882. View below or at eCFR (GPOAccess)
§ 882.1935 Near Infrared (NIR) Brain Hematoma Detector.
(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.
[77 FR 16927, Mar. 23, 2012]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-07-08; vol. 79 # 130 - Tuesday, July 8, 2014
    1. 79 FR 38457 - Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulator for Headache
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective August 7, 2014. The classification was applicable on December 13, 2013.
      21 CFR Part 882

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 882 after this date.

  • 2014-07-08; vol. 79 # 130 - Tuesday, July 8, 2014
    1. 79 FR 38457 - Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulator for Headache
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective August 7, 2014. The classification was applicable on December 13, 2013.
      21 CFR Part 882