CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR882]

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
					
SUBCHAPTER H - MEDICAL DEVICES
					
							PART 882NEUROLOGICAL DEVICES

Subpart B - Neurological Diagnostic Devices

Sec. 882.1020 Rigidity analyzer.

(a) Identification. A rigidity analyzer is a device for quantifying the extent of the rigidity of a patient's limb to determine the effectiveness of drugs or other treatments.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]

Sec. 882.1030 Ataxiagraph.

(a) Identification. An ataxiagraph is a device used to determine the extent of ataxia (failure of muscular coordination) by measuring the amount of swaying of the body when the patient is standing erect and with eyes closed.

(b) Classification. Class I (general controls). Except when the device is intended to provide an interpretation or a clinical implication of the measurement, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 66 FR 46952, Sept. 10, 2001; 84 FR 71815, Dec. 30, 2019]

Sec. 882.1200 Two-point discriminator.

(a) Identification. A two-point discriminator is a device with points used for testing a patient's touch discrimination.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000]

Sec. 882.1240 Echoencephalograph.

(a) Identification. An echoencephalograph is an ultrasonic scanning device (including A-scan, B-scan, and doppler systems) that uses noninvasive transducers for measuring intracranial interfaces and blood flow velocity to and in the head.

(b) Classification. Class II (performance standards).

Sec. 882.1275 Electroconductive media.

(a) Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.

(b) Classification. Class II (performance standards).

Sec. 882.1310 Cortical electrode.

(a) Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.

(b) Classification. Class II (performance standards).

Sec. 882.1320 Cutaneous electrode.

(a) Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

(b) Classification. Class II (performance standards).

Sec. 882.1330 Depth electrode.

(a) Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

(b) Classification. Class II (performance standards).

Sec. 882.1340 Nasopharyngeal electrode.

(a) Identification. A nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording electrical activity.

(b) Classification. Class II (performance standards).

Sec. 882.1350 Needle electrode.

(a) Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

(b) Classification. Class II (performance standards).

Sec. 882.1400 Electroencephalograph.

(a) Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

(b) Classification. Class II (performance standards).

Sec. 882.1410 Electroencephalograph electrode/lead tester.

(a) Identification. An electroencephalograph electrode/lead tester is a device used for testing the impedance (resistance to alternating current) of the electrode and lead system of an electroencephalograph to assure that an adequate contact is made between the electrode and the skin.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38807, July 25, 2001]

Sec. 882.1420 Electroencephalogram (EEG) signal spectrum analyzer.

(a) Identification. An electroencephalogram (EEG) signal spectrum analyzer is a device used to display the frequency content or power spectral density of the electroencephalogram (EEG) signal.

(b) Classification. Class I (general controls).

[44 FR 51730, Sept. 4, 1979, as amended at 66 FR 46953, Sept. 10, 2001]

Sec. 882.1430 Electroencephalograph test signal generator.

(a) Identification. An electroencephalograph test signal generator is a device used to test or calibrate an electroencephalograph.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001]

Sec. 882.1440 Neuropsychiatric interpretive electroencephalograph assessment aid.

(a) Identification. The neuropsychiatric interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. The neuropsychiatric interpretive EEG assessment aid is used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.

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

(1) The technical parameters of the device, hardware and software, must be fully characterized and must demonstrate a reasonable assurance of safety and effectiveness.

(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.

(ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification and software design specification. Appropriate software verification, validation, and hazard analysis must be performed.

(2) The device parts that contact the patient must be demonstrated to be biocompatible.

(3) The device must be designed and tested for electrical safety, electromagnetic compatibility, thermal, and mechanical safety.

(4) Clinical performance testing must demonstrate the accuracy, precision, reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs).

(5) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value, and negative predictive value per the device intended use. Repeatability of measurements must be demonstrated using interclass correlation coefficients and illustrated by qualitative scatter plot(s).

(6) The device design must include safeguards to prevent use of the device as a stand-alone diagnostic.

(7) The labeling must include the following information:

(i) A warning that the device is not to be used as a stand-alone diagnostic.

(ii) A detailed summary of the clinical performance testing, including any adverse events and complications.

(iii) The qualifications and training requirements for device users including technicians and clinicians.

(iv) The intended use population and the intended use environment.

(v) Any instructions technicians should convey to patients regarding the collection of EEG data.

(vi) Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway.

(vii) Where appropriate, validated methods and instructions for reprocessing of any reusable components.

[79 FR 9085, Feb. 18, 2014]

Sec. 882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid.

(a) Identification. A brain injury adjunctive interpretive electroencephalograph assessment aid is a prescription device that uses a patient's electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient's brain in the setting of trauma. A brain injury adjunctive interpretive EEG assessment aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.

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

(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:

(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.

(ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.

(2) The device parts that contact the patient must be demonstrated to be biocompatible.

(3) The device must be designed and tested for electrical safety, electromagnetic compatibility (EMC), thermal, and mechanical safety.

(4) Clinical performance testing must demonstrate the accuracy, precision-repeatability and reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs).

(5) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) with respect to the study prevalence per the device intended use.

(6) The device design must include safeguards to ensure appropriate clinical interpretation of the device output (e.g., use in appropriate patient population, or for appropriate clinical decision).

(7) The labeling and training information must include:

(i) A warning that the device is not to be used as a stand-alone diagnostic.

(ii) A detailed summary of the clinical performance testing, including any adverse events and complications.

(iii) The intended use population and the intended use environment.

(iv) Any instructions technicians should convey to patients regarding the collection of EEG data.

(v) Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway.

(vi) Information allowing clinicians to understand how to integrate the device output into their diagnostic pathway when the device is unable to provide a classification or final result.

[80 FR 16268, Mar. 27, 2015]

Sec. 882.1455 Traumatic brain injury eye movement assessment aid.

(a) Identification. A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient's tracked eye movements to provide an interpretation of the functional condition of the patient's brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.

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

(1) Clinical performance data under anticipated conditions of use must evaluate tracked eye movement in supporting the indications for use and include the following:

(i) Evaluation of sensitivity, specificity, positive predictive value, and negative predictive value using a reference method of diagnosis;

(ii) Evaluation of device test-retest reliability; and

(iii) A description of the development of the reference method of diagnosis, which may include a normative database, to include the following:

(A) A discussion of how the clinical work-up was completed to establish the reference method of diagnosis, including the establishment of inclusion and exclusion criteria; and

(B) If using a normative database, a description of how the "normal" population was established, and the statistical methods and model assumptions used.

(2) Software verification, validation, and hazard analysis must be performed. Software documentation must include a description of the algorithms used to generate device output.

(3) Performance testing must demonstrate the electrical safety and electromagnetic compatibility (EMC) of the device.

(4) The patient-contacting components of the device must be demonstrated to be biocompatible.

(5) A light hazard assessment must be performed for all eye-tracking and visual display light sources.

(6) Labeling must include:

(i) A summary of clinical performance testing conducted with the device, including sensitivity, specificity, positive predictive value, negative predictive value, and test-retest reliability;

(ii) A description of any normative database that includes the following:

(A) The clinical definition used to establish a "normal" population and the specific selection criteria;

(B) The format for reporting normal values;

(D) Statistical methods and model assumptions; and

(E) Any adjustments for age and gender.

(iii) A warning that the device should only be used by trained healthcare professionals;

(iv) A warning that the device does not identify the presence or absence of traumatic brain injury or other clinical diagnoses;

(v) A warning that the device is not a standalone diagnostic; and

(vi) Any instructions to convey to patients regarding the administration of the test and collection of test data.

[86 FR 71384, Dec. 16, 2021]

Sec. 882.1460 Nystagmograph.

(a) Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

(b) Classification. Class II (performance standards).

Sec. 882.1470 Computerized cognitive assessment aid.

(a) Identification. The computerized cognitive assessment aid is a prescription device that uses an individual's score(s) on a battery of cognitive tasks to provide an interpretation of the current level of cognitive function. The computerized cognitive assessment aid is used only as an assessment aid to determine level of cognitive functioning for which there exists other valid methods of cognitive assessment and does not identify the presence or absence of clinical diagnoses. The computerized cognitive assessment aid is not intended as a stand-alone or adjunctive diagnostic device.

(b) Classification. Class II (special controls). Except when the computerized cognitive assessment aid is intended for diagnostic assessment of specific diseases or conditions and relies on inputs from visual cues, auditory cues, and/or functional use of the hand, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The special control(s) for this device are:

(1) The technical parameters of the device's hardware and software must be fully characterized and be accompanied by appropriate non-clinical testing:

(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.

(ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's cognitive function, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.

(2) The device must be designed and tested for electrical safety.

(3) The labeling must include:

(i) A summary of any testing conducted to demonstrate how the device functions as an interpretation of the current level of cognitive function. The summary of testing must include the following, if available: Any expected or observed adverse events and complications; any performance measurements including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) per the devices intended use; a description of the repeatability of measurements; a description of how the cut-off values for categorization of measurements were determined; and a description of the construct validity of the device.

(ii) A warning that the device does not identify the presence or absence of clinical diagnoses.

(iii) A warning that the device is not a stand-alone diagnostic.

(iv) The intended use population and the intended use environment.

(v) Any instructions technicians must convey to patients regarding the administration of the test and collection of cognitive test data.

[80 FR 49138, Aug. 17, 2015, as amended at 84 FR 71815, Dec. 30, 2019]

Sec. 882.1471 Computerized cognitive assessment aid for concussion.

(a) Identification. The computerized cognitive assessment aid for concussion is a prescription device that uses an individual's score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to concussion. The computerized cognitive assessment aid for concussion is used only as an assessment aid in the management of concussion to determine cognitive function for patients after a potential concussive event where other diagnostic tools are available and does not identify the presence or absence of concussion. It is not intended as a stand-alone diagnostic device.

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

(1) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's cognitive function, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed.

(2) Clinical performance data must be provided that demonstrates how the device functions as an interpretation of the current level of cognitive function in an individual that has recently received an injury that causes concern about a possible concussion. The testing must:

(i) Evaluate device output and clinical interpretation.

(ii) Evaluate device test-retest reliability of the device output.

(iii) Evaluate construct validity of the device cognitive assessments.

(iv) Describe the construction of the normative database, which includes the following:

(A) How the clinical workup was completed to establish a "normal" population, including the establishment of inclusion and exclusion criteria.

(B) Statistical methods and model assumptions used.

(3) The labeling must include:

(i) A summary of any clinical testing conducted to demonstrate how the device functions as an interpretation of the current level of cognitive function in a patient that has recently received an injury that causes concern about a possible concussion. The summary of testing must include the following:

(A) Device output and clinical interpretation.

(B) Device test-retest reliability of the device output.

(D) A description of the normative database, which includes the following:

(1 ) How the clinical workup was completed to establish a "normal" population, including the establishment of inclusion and exclusion criteria.

(2 ) How normal values will be reported to the user.

(3 ) Representative screen shots and reports that will be generated to provide the user results and normative data.

(4 ) Statistical methods and model assumptions used.

(5 ) Whether or not the normative database was adjusted due to differences in age and gender.

(ii) A warning that the device should only be used by health care professionals who are trained in concussion management.

(iii) A warning that the device does not identify the presence or absence of concussion or other clinical diagnoses.

(iv) A warning that the device is not a stand-alone diagnostic.

(v) Any instructions technicians must convey to patients regarding the administration of the test and collection of cognitive test data.

[81 FR 87811, Dec. 6, 2016]

Sec. 882.1480 Neurological endoscope.

(a) Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

(b) Classification. Class II (performance standards).

Sec. 882.1491 Pediatric Autism Spectrum Disorder diagnosis aid.

(a) Identification. A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients.

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

(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including an evaluation of sensitivity, specificity, positive predictive value, and negative predictive value using a reference method of diagnosis and assessment of patient behavioral symptomology.

(2) Software verification, validation, and hazard analysis must be provided. Software documentation must include a detailed, technical description of the algorithm(s) used to generate device output(s), and a cybersecurity assessment of the impact of threats and vulnerabilities on device functionality and user(s).

(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.

(4) Labeling must include:

(i) Instructions for use, including a detailed description of the device, compatibility information, and information to facilitate clinical interpretation of all device outputs; and

(ii) A summary of any clinical testing conducted to demonstrate how the device functions as an interpretation of patient behavioral symptomology associated with Autism Spectrum Disorder. The summary must include the following:

(A) A description of each device output and clinical interpretation;

(B) Any performance measures, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV);

(D) Any expected or observed adverse events and complications.

(iii) A statement that the device is not intended for use as a stand-alone diagnostic.

[87 FR 80445, Dec. 30, 2022]

Sec. 882.1500 Esthesiometer.

(a) Identification. An esthesiometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician or other examiner and which is used to determine whether a patient has tactile sensitivity.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000]

Sec. 882.1525 Tuning fork.

(a) Identification. A tuning fork is a mechanical device which resonates at a given frequency and is used to diagnose hearing disorders and to test for vibratory sense.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 66 FR 38807, July 25, 2001]

Sec. 882.1540 Galvanic skin response measurement device.

(a) Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]

Sec. 882.1550 Nerve conduction velocity measurement device.

(a) Identification. A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

(b) Classification. Class II (performance standards).

Sec. 882.1560 Skin potential measurement device.

(a) Identification. A skin potential measurement device is a general diagnostic device used to measure skin voltage by means of surface skin electrodes.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]

Sec. 882.1561 Evoked photon image capture device.

(a) Identification. An evoked photon image capture device is a prescription, electrically powered device intended for use as a noninvasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are reported numerically and as images without clinical interpretation. The device is not intended for diagnostic purposes.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 882.9.

[81 FR 67155, Sept. 30, 2016]

Sec. 882.1570 Powered direct-contact temperature measurement device.

(a) Identification. A powered direct-contact temperature measurement device is a device which contains a power source and is used to measure differences in temperature between two points on the body.

(b) Classification. Class II (performance standards).

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

(a) Identification. A non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system is a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure.

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

(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:

(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.

(ii) Software, including any proprietary algorithm(s) used by the device to achieve its intended use, must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) The device must be designed and tested for electrical, thermal, and mechanical safety and electromagnetic compatibility (EMC).

(4) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for monitoring for seizure-related activity in the intended population and for the intended use setting. Performance measurements must include positive percent agreement and false alarm rate.

(5) Training must be provided for intended users that includes information regarding the proper use of the device and factors that may affect the collection of the physiologic data.

(6) The labeling must include health care professional labeling and patient-caregiver labeling. The health care professional and the patient-caregiver labeling must include the following information:

(i) A detailed summary of the clinical performance testing, including any adverse events and complications.

(ii) Any instructions technicians and clinicians should convey to patients and caregivers regarding the proper use of the device and factors that may affect the collection of the physiologic data.

(iii) Instructions to technicians and clinicians regarding how to set the device threshold to achieve the intended performance of the device.

[82 FR 50082, Oct. 30, 2017]

Sec. 882.1610 Alpha monitor.

(a) Identification. An alpha monitor is a device with electrodes that are placed on a patient's scalp to monitor that portion of the electroencephalogram which is referred to as the alpha wave.

(b) Classification. Class II (performance standards).

Sec. 882.1620 Intracranial pressure monitoring device.

(a) Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.

(b) Classification. Class II (performance standards).

Sec. 882.1630 Cranial motion measurement device.

(a) Identification. A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes.

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

(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:

(i) Hardware specifications must be provided. Additionally, verification and validation testing as well as a hazard analysis must be performed.

(ii) Software must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Additionally, software verification and validation testing as well as a hazard analysis must be performed.

(2) The device parts that contact the patient must be demonstrated to be biocompatible.

(3) The device must be designed and tested for electrical, thermal, and mechanical safety, and electromagnetic compatibility (EMC).

(4) Clinical performance testing must demonstrate the accuracy, precision, stability, and repeatability of measuring cranial motion per the intended use in the intended use environment.

(5) The labeling must include:

(i) The intended use population and the intended use environment.

(ii) Instructions for technicians to convey to patients regarding the collection of cranial acceleration data to ensure device measurement accuracy, precision, stability, and repeatability.

(iii) Information allowing clinicians to understand potential sources of variability in the measurement to help recognize and identify changes in the measurement.

[82 FR 35071, July 28, 2017]

Sec. 882.1700 Percussor.

(a) Identification. A percussor is a small hammerlike device used by a physician to provide light blows to a body part. A percussor is used as a diagnostic aid during physical examinations.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001]

Sec. 882.1750 Pinwheel.

(a) Identification. A pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000]

Sec. 882.1790 Ocular plethysmograph.

(a) Identification. An ocular plethysmograph is a device used to measure or detect volume changes in the eye produced by pulsations of the artery, to diagnose carotid artery occlusive disease (restrictions on blood flow in the carotid artery).

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any ocular plethysmograph that was in commercial distribution before May 28, 1976. Any other ocular plethysmograph shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17739, May 11, 1987; 69 FR 34920, June 23, 2004]

Sec. 882.1825 Rheoencephalograph.

(a) Identification. A rheoencephalograph is a device used to estimate a patient's cerebral circulation (blood flow in the brain) by electrical impedance methods with direct electrical connections to the scalp or neck area.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any rheoencephalograph that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a rheoencephalograph that was in commercial distribution before May 28, 1976. Any other rheoencephalograph shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, 1996]

Sec. 882.1835 Physiological signal amplifier.

(a) Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).

(b) Classification. Class II (performance standards).

Sec. 882.1845 Physiological signal conditioner.

(a) Identification. A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals for recording and processing.

(b) Classification. Class II (performance standards).

Sec. 882.1855 Electroencephalogram (EEG) telemetry system.

(a) Identification. An electroencephalogram (EEG) telemetry system consists of transmitters, receivers, and other components used for remotely monitoring or measuring EEG signals by means of radio or telephone transmission systems.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019]

Sec. 882.1870 Evoked response electrical stimulator.

(a) Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

(b) Classification. Class II (performance standards).

Sec. 882.1880 Evoked response mechanical stimulator.

(a) Identification. An evoked response mechanical stimulator is a device used to produce a mechanical stimulus or a series of mechanical stimuli for the purpose of measuring a patient's evoked response.

(b) Classification. Class II (performance standards).

Sec. 882.1890 Evoked response photic stimulator.

(a) Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.

(b) Classification. Class II (performance standards).

Sec. 882.1900 Evoked response auditory stimulator.

(a) Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

(b) Classification. Class II (performance standards).

Sec. 882.1925 Ultrasonic scanner calibration test block.

(a) Identification. An ultrasonic scanner calibration test block is a block of material with known properties used to calibrate ultrasonic scanning devices (e.g., the echoencephalograph).

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001]

Sec. 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]

Sec. 882.1950 Tremor transducer.

(a) Identification. A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.

(b) Classification. Class II (performance standards).

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

CFR - Code of Federal Regulations Title 21

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