FDA 21 CFR Part 882 Neurological Devices

Click the title below for complete guidelines

Table of contents

Subpart A - General Provisions

882.1 Scope.

882.3 Effective dates of requirement for premarket approval.

882.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B - Neurological Diagnostic Devices

882.1020 Rigidity analyzer.

882.1030 Ataxiagraph.

882.1200 Two-point discriminator.

882.1240 Echoencephalograph.

882.1275 Electroconductive media.

882.1310 Cortical electrode.

882.1320 Cutaneous electrode.

882.1330 Depth electrode.

882.1340 Nasopharyngeal electrode.

882.1350 Needle electrode.

882.1400 Electroencephalograph.

882.1410 Electroencephalograph electrode/lead tester.

882.1420 Electroencephalogram (EEG) signal spectrum analyzer.

882.1430 Electroencephalograph test signal generator.

882.1440 Neuropsychiatric interpretive electroencephalograph assessment aid.

882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.

882.1460 Nystagmograph.

882.1470 Computerized cognitive assessment aid.

882.1471 Computerized cognitive assessment aid for concussion.

882.1480 Neurological endoscope.

882.1500 Esthesiometer.

882.1525 Tuning fork.

882.1540 Galvanic skin response measurement device.

882.1550 Nerve conduction velocity measurement device.

882.1560 Skin potential measurement device.

882.1561 Evoked photon image capture device.

882.1570 Powered direct-contact temperature measurement device.

882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.

882.1610 Alpha monitor.

882.1620 Intracranial pressure monitoring device.

882.1630 Cranial motion measurement device.

882.1700 Percussor.

882.1750 Pinwheel.

882.1790 Ocular plethysmograph.

882.1825 Rheoencephalograph.

882.1835 Physiological signal amplifier.

882.1845 Physiological signal conditioner.

882.1855 Electroencephalogram (EEG) telemetry system.

882.1870 Evoked response electrical stimulator.

882.1880 Evoked response mechanical stimulator.

882.1890 Evoked response photic stimulator.

882.1900 Evoked response auditory stimulator.

882.1925 Ultrasonic scanner calibration test block.

882.1935 Near Infrared (NIR) Brain Hematoma Detector.

882.1950 Tremor transducer.

Subparts C-D [Reserved]

Subpart E - Neurological Surgical Devices, (and)

Subpart F - Neurological Therapeutic Devices

FDA 21 CFR Part 882 Neurological Devices: