cfr_sections
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140 rows where agency = "FDA" and part_number = 882 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 21:21:8.0.1.1.28.1.1.1 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | A | Subpart A—General Provisions | § 882.1 Scope. | FDA | [52 FR 17739, May 11, 1987, as amended at 68 FR 70436, Dec. 18, 2003; 78 FR 18233, Mar. 26, 2013] | (a) This part sets forth the classification of neurological devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87. (c) To avoid duplicative listings, a neurological device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed only in one subpart. (d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. (e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.. | |||
| 21:21:8.0.1.1.28.1.1.2 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | A | Subpart A—General Provisions | § 882.3 Effective dates of requirement for premarket approval. | FDA | [52 FR 17739, May 11, 1987] | A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device. (a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section, 501(f)(1)(A) of the act applies to the device. (b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a P… | |||
| 21:21:8.0.1.1.28.1.1.3 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | A | Subpart A—General Provisions | § 882.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). | FDA | [65 FR 2319, Jan. 14, 2000] | The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when: (a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; (b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or (c) The device is an in vitro device that is intended: (1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism; (3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chroni… | |||
| 21:21:8.0.1.1.28.2.1.1 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1020 Rigidity analyzer. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019] | (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. | |||
| 21:21:8.0.1.1.28.2.1.10 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1350 Needle electrode. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.11 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1400 Electroencephalograph. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.12 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1410 Electroencephalograph electrode/lead tester. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38807, July 25, 2001] | (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. | |||
| 21:21:8.0.1.1.28.2.1.13 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1420 Electroencephalogram (EEG) signal spectrum analyzer. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 66 FR 46953, Sept. 10, 2001] | (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). | |||
| 21:21:8.0.1.1.28.2.1.14 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1430 Electroencephalograph test signal generator. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001] | (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. | |||
| 21:21:8.0.1.1.28.2.1.15 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1440 Neuropsychiatric interpretive electroencephalograph assessment aid. | FDA | [79 FR 9085, Feb. 18, 2014] | (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 c… | |||
| 21:21:8.0.1.1.28.2.1.16 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid. | FDA | [80 FR 16268, Mar. 27, 2015] | (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 (N… | |||
| 21:21:8.0.1.1.28.2.1.17 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1455 Traumatic brain injury eye movement assessment aid. | FDA | [86 FR 71384, Dec. 16, 2021] | (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 follo… | |||
| 21:21:8.0.1.1.28.2.1.18 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1460 Nystagmograph. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.19 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1470 Computerized cognitive assessment aid. | FDA | [80 FR 49138, Aug. 17, 2015, as amended at 84 FR 71815, Dec. 30, 2019] | (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 perf… | |||
| 21:21:8.0.1.1.28.2.1.2 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1030 Ataxiagraph. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 66 FR 46952, Sept. 10, 2001; 84 FR 71815, Dec. 30, 2019] | (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. | |||
| 21:21:8.0.1.1.28.2.1.20 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1471 Computerized cognitive assessment aid for concussion. | FDA | [81 FR 87811, Dec. 6, 2016] | (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 injur… | |||
| 21:21:8.0.1.1.28.2.1.21 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1480 Neurological endoscope. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.22 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1491 Pediatric Autism Spectrum Disorder diagnosis aid. | FDA | [87 FR 80445, Dec. 30, 2022] | (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); (C) A description of how the cutoff values used for categorical classification of diagnoses were determined; and (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. | |||
| 21:21:8.0.1.1.28.2.1.23 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1500 Esthesiometer. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000; 90 FR 55989, Dec. 4, 2025] | (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. (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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter. | |||
| 21:21:8.0.1.1.28.2.1.24 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1525 Tuning fork. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 66 FR 38807, July 25, 2001; 90 FR 55989, Dec. 4, 2025] | (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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter. | |||
| 21:21:8.0.1.1.28.2.1.25 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1540 Galvanic skin response measurement device. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019] | (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. | |||
| 21:21:8.0.1.1.28.2.1.26 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1550 Nerve conduction velocity measurement device. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.27 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1560 Skin potential measurement device. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019] | (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. | |||
| 21:21:8.0.1.1.28.2.1.28 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1561 Evoked photon image capture device. | FDA | [81 FR 67155, Sept. 30, 2016] | (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. | |||
| 21:21:8.0.1.1.28.2.1.29 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1570 Powered direct-contact temperature measurement device. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.3 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1200 Two-point discriminator. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000; 90 FR 55989, Dec. 4, 2025] | (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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter. | |||
| 21:21:8.0.1.1.28.2.1.30 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system. | FDA | [82 FR 50082, Oct. 30, 2017] | (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 re… | |||
| 21:21:8.0.1.1.28.2.1.31 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1610 Alpha monitor. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.32 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1620 Intracranial pressure monitoring device. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.33 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1630 Cranial motion measurement device. | FDA | [82 FR 35071, July 28, 2017] | (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. | |||
| 21:21:8.0.1.1.28.2.1.34 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1700 Percussor. | FDA | [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; 90 FR 55989, Dec. 4, 2025] | (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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter. | |||
| 21:21:8.0.1.1.28.2.1.35 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1750 Pinwheel. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000] | (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. | |||
| 21:21:8.0.1.1.28.2.1.36 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1790 Ocular plethysmograph. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17739, May 11, 1987; 69 FR 34920, June 23, 2004] | (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. | |||
| 21:21:8.0.1.1.28.2.1.37 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1825 Rheoencephalograph. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, 1996] | (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. | |||
| 21:21:8.0.1.1.28.2.1.38 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1835 Physiological signal amplifier. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.39 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1845 Physiological signal conditioner. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.4 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1240 Echoencephalograph. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.40 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1855 Electroencephalogram (EEG) telemetry system. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019] | (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. | |||
| 21:21:8.0.1.1.28.2.1.41 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1870 Evoked response electrical stimulator. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.42 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1880 Evoked response mechanical stimulator. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.43 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1890 Evoked response photic stimulator. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.44 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1900 Evoked response auditory stimulator. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.45 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1925 Ultrasonic scanner calibration test block. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001] | (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. | |||
| 21:21:8.0.1.1.28.2.1.46 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1935 Near Infrared (NIR) Brain Hematoma Detector. | FDA | [77 FR 16927, Mar. 23, 2012] | (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. | |||
| 21:21:8.0.1.1.28.2.1.47 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1950 Tremor transducer. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.5 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1275 Electroconductive media. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.6 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1310 Cortical electrode. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.7 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1320 Cutaneous electrode. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.8 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1330 Depth electrode. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.2.1.9 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | B | Subpart B—Neurological Diagnostic Devices | § 882.1340 Nasopharyngeal electrode. | FDA | (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). | ||||
| 21:21:8.0.1.1.28.4.1.1 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4030 Skull plate anvil. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38808, July 25, 2001] | (a) Identification. A skull plate anvil is a device used to form alterable skull plates in the proper shape to fit the curvature of a patient's skull. (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. | |||
| 21:21:8.0.1.1.28.4.1.10 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4250 Cryogenic surgical device. | FDA | (a) Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.11 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4275 Dowel cutting instrument. | FDA | (a) Identification. A dowel cutting instrument is a device used to cut dowels of bone for bone grafting. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.12 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4300 Manual cranial drills, burrs, trephines, and their accessories | FDA | (a) Identification. Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.13 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories. | FDA | (a) Identification. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.14 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories. | FDA | (a) Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.15 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4325 Cranial drill handpiece (brace). | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, 2001] | (a) Identification. A cranial drill handpiece (brace) is a hand holder, which is used without a power source, for drills, burrs, trephines, or other cutting tools that are used on a patient's skull. (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. | |||
| 21:21:8.0.1.1.28.4.1.16 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4360 Electric cranial drill motor. | FDA | (a) Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.17 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4370 Pneumatic cranial drill motor. | FDA | (a) Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.18 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4400 Radiofrequency lesion generator. | FDA | (a) Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.19 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4440 Neurosurgical headrests. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] | (a) Identification. A neurosurgical headrest is a device used to support the patient's head during a surgical procedure. (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. | |||
| 21:21:8.0.1.1.28.4.1.2 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4060 Ventricular cannula. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000; 84 FR 71815, Dec. 30, 2019] | (a) Identification. A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle. (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. | |||
| 21:21:8.0.1.1.28.4.1.20 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4460 Neurosurgical head holder (skull clamp). | FDA | (a) Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.21 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4500 Cranioplasty material forming instrument. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] | (a) Identification. A cranioplasty material forming instrument is a roller used in the preparation and forming of cranioplasty (skull repair) materials. (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. | |||
| 21:21:8.0.1.1.28.4.1.22 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4525 Microsurgical instrument. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] | (a) Identification. A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures. (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. | |||
| 21:21:8.0.1.1.28.4.1.23 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4535 Nonpowered neurosurgical instrument. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] | (a) Identification. A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc. (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. | |||
| 21:21:8.0.1.1.28.4.1.24 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4545 Shunt system implantation instrument. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000; 84 FR 71815, Dec. 30, 2019] | (a) Identification. A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under 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. | |||
| 21:21:8.0.1.1.28.4.1.25 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4560 Stereotaxic instrument. | FDA | (a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.26 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4565 Field generator positioning device. | FDA | [90 FR 54234, Nov. 26, 2025] | (a) Identification. A field generator positioning device is a manual, mechanical device intended to position the field generator of an electromagnetic based stereotaxic navigation system in proximity to a patient. The device may operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, by using a mechanical interface. (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. | |||
| 21:21:8.0.1.1.28.4.1.27 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4600 Leukotome. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] | (a) Identification. A leukotome is a device used to cut sections out of the brain. (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. | |||
| 21:21:8.0.1.1.28.4.1.28 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4650 Neurosurgical suture needle. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000] | (a) Identification. A neurosurgical suture needle is a needle used in suturing during neurosurgical procedures or in the repair of nervous tissue. (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. | |||
| 21:21:8.0.1.1.28.4.1.29 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4700 Neurosurgical paddie. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 69 FR 10332, Mar. 5, 2004] | (a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding. (b) Classification. Class II (performance standards). | |||
| 21:21:8.0.1.1.28.4.1.3 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4100 Ventricular catheter. | FDA | (a) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.30 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4725 Radiofrequency lesion probe. | FDA | (a) Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.31 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4750 Skull punch. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000] | (a) Identification. A skull punch is a device used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flaps by wire or other means. (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. This exemption does not apply to powered compound cranial drills, burrs, trephines, and their accessories classified under § 882.4305. | |||
| 21:21:8.0.1.1.28.4.1.32 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4800 Self-retaining retractor for neurosurgery. | FDA | (a) Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.33 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4840 Manual rongeur. | FDA | (a) Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.34 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4845 Powered rongeur. | FDA | (a) Identification. A powered rongeur is a powered instrument used for cutting or biting bone during surgery involving the skull or spinal column. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.35 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4900 Skullplate screwdriver. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] | (a) Identification. A skullplate screwdriver is a tool used by the surgeon to fasten cranioplasty plates or skullplates to a patient's skull by screws. (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. | |||
| 21:21:8.0.1.1.28.4.1.36 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4950 Diagnostic neurosurgical microscope filter. | FDA | [86 FR 73973, Dec. 29, 2021] | (a) Identification. A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition. (b) Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, and verify and validate filter specifications and functional characteristics, including the following: (i) Spectrum and intensity of the illumination source; (ii) Spectrum of the excitation and emission filter modules when integrated in the surgical operating microscope; (iii) Excitation power and power density; (iv) Optical path loss from illumination source to objective lens or microscope camera; (v) Homogeneity of the excitation light at the focal plane; (vi) Fluorescence detection sensitivity; (vii) Verification of calibration or preoperative procedures; and (viii) If camera-based, spectral sensitivity of the camera. (2) Labeling must include: (i) Identification of the filter characteristics in conjunction with a compatible surgical operating microscope, to include the following: (A) Illumination spectrum and power density; and (B) Excitation and emission filter spectra. (ii) Instructions for calibration or preoperative checks to ensure device functionality prior to each use; (iii) Instructions for use with compatible surgical operating microscopes, external light sources, and cameras; (iv) A warning that the device should only be used with fluorophores approved for use within the specified spectral ranges; and (v) A warning that the device is not a standalone diagnostic. | |||
| 21:21:8.0.1.1.28.4.1.4 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4125 Neurosurgical chair. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] | (a) Identification. A neurosurgical chair is an operating room chair used to position and support a patient during neurosurgery. (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. | |||
| 21:21:8.0.1.1.28.4.1.5 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4150 Scalp clip. | FDA | (a) Identification. A scalp clip is a plastic or metal clip used to stop bleeding during surgery on the scalp. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.6 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4175 Aneurysm clip applier. | FDA | (a) Identification. An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.4.1.7 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4190 Clip forming/cutting instrument. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994] | (a) Identification. A clip forming/cutting instrument is a device used by the physician to make tissue clips from wire stock. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. | |||
| 21:21:8.0.1.1.28.4.1.8 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4200 Clip removal instrument. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] | (a) Identification. A clip removal instrument is a device used to remove surgical clips from the patient. (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. | |||
| 21:21:8.0.1.1.28.4.1.9 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | E | Subpart E—Neurological Surgical Devices | § 882.4215 Clip rack. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] | (a) Identification. A clip rack is a device used to hold or store surgical clips during surgery. (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. | |||
| 21:21:8.0.1.1.28.5.1.1 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | F | Subpart F—Neurological Therapeutic Devices | § 882.5030 Methyl methacrylate for aneurysmorrhaphy. | FDA | (a) Identification. Methyl methacrylate for aneurysmorrhaphy (repair of aneurysms, which are balloonlike sacs formed on blood vessels) is a self-curing acrylic used to encase and reinforce intracranial aneurysms that are not amenable to conservative management, removal, or obliteration by aneurysm clip. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.5.1.10 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | F | Subpart F—Neurological Therapeutic Devices | § 882.5250 Burr hole cover. | FDA | (a) Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.5.1.11 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | F | Subpart F—Neurological Therapeutic Devices | § 882.5275 Nerve cuff. | FDA | (a) Identification. A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors). (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.5.1.12 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | F | Subpart F—Neurological Therapeutic Devices | § 882.5300 Methyl methacrylate for cranioplasty. | FDA | (a) Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.5.1.13 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | F | Subpart F—Neurological Therapeutic Devices | § 882.5320 Preformed alterable cranioplasty plate. | FDA | (a) Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.5.1.14 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | F | Subpart F—Neurological Therapeutic Devices | § 882.5330 Preformed nonalterable cranioplasty plate. | FDA | (a) Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.5.1.15 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | F | Subpart F—Neurological Therapeutic Devices | § 882.5360 Cranioplasty plate fastener. | FDA | (a) Identification. A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.5.1.16 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | F | Subpart F—Neurological Therapeutic Devices | § 882.5500 Lesion temperature monitor. | FDA | (a) Identification. A lesion temperature monitor is a device used to monitor the tissue temperature at the site where a lesion (tissue destruction) is to be made when a surgeon uses a radiofrequency (RF) lesion generator and probe. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.5.1.17 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | F | Subpart F—Neurological Therapeutic Devices | § 882.5550 Central nervous system fluid shunt and components. | FDA | (a) Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt. (b) Classification. Class II (performance standards). | ||||
| 21:21:8.0.1.1.28.5.1.18 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | F | Subpart F—Neurological Therapeutic Devices | § 882.5560 Cerebrospinal fluid shunt system. | FDA | [86 FR 73975, Dec. 29, 2021] | (a) Identification. A cerebrospinal fluid shunt system is a prescription device used to monitor and divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of preventing spinal cord ischemia or injury during procedures that require reduction in central nervous system pressure. A cerebrospinal fluid shunt system may include catheters, valved catheters, valves, connectors, and pressure monitors intended to facilitate use of the shunt or evaluation of a patient with a shunt. (b) Classification. Class II (special controls). The special controls for this device are: (1) The device description must include a detailed summary of the device technical parameters, including design configuration, dimensions, engineering drawings, and a list of all components with identification of their materials of construction. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Simulated use testing must be conducted to characterize fluid flow and resistance to leakage; and (ii) Mechanical integrity testing of all connections must be conducted. (4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf life. (5) Performance data must demonstrate the sterility and pyrogenicity of patient-contacting components of the device. (6) The labeling must include: (i) Contraindications with respect to patients who should not receive a lumbar drain; (ii) A warning that the device should have 24-hour-a-day availability of trained personnel to supervise monitoring and drainage; (iii) Instructions on proper device setup, positioning, and monitoring; (iv) Warnings and precautions to inform the user of serious hazar… | |||
| 21:21:8.0.1.1.28.5.1.19 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | F | Subpart F—Neurological Therapeutic Devices | § 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment. | FDA | [81 FR 94253, Dec. 23, 2016] | (a) Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient contacting components of the device must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including: (i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces. (ii) Mechanical testing to evaluate the radial forces exerted by the device. (iii) Non-clinical testing to verify the dimensions of the device. (iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions. (v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized. (vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions. (vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions. (3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device. (4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life. (5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure. (6) The labeling must incl… | |||
| 21:21:8.0.1.1.28.5.1.2 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | F | Subpart F—Neurological Therapeutic Devices | § 882.5050 Biofeedback device. | FDA | [44 FR 51730, Sept. 4, 1979, as amended at 63 FR 59229, Nov. 3, 1998] | (a) Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9. | |||
| 21:21:8.0.1.1.28.5.1.20 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | F | Subpart F—Neurological Therapeutic Devices | § 882.5700 Thermal system for insomnia. | FDA | [81 FR 44772, July 11, 2016] | (a) Identification. A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface. (b) Classification. Class II (special controls). The special controls for this device are: (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance testing must demonstrate electromagnetic compatibility and electrical safety. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Thermal performance of the device, including maintenance of the target temperature, must be evaluated under simulated use conditions. (ii) Mechanical testing to demonstrate the device can withstand forces under anticipated use conditions. (iii) Mechanical testing to demonstrate the device is resistant to leakage under anticipated use conditions. (4) Software verification, validation, and hazard analysis must be performed. (5) Patient labeling must be provided to convey information regarding safe use of the device, including instructions for assembly. | |||
| 21:21:8.0.1.1.28.5.1.21 | 21 | Food and Drugs | I | H | 882 | PART 882—NEUROLOGICAL DEVICES | F | Subpart F—Neurological Therapeutic Devices | § 882.5705 Digital therapy device to reduce sleep disturbance for psychiatric conditions. | FDA | [88 FR 2223, Jan. 13, 2023] | (a) Identification. A digital therapy device to reduce sleep disturbance for psychiatric conditions is a prescription device that is intended to provide stimulation using a general purpose computing platform to reduce sleep disturbance in patients who experience this symptom due to psychiatric conditions such as nightmare disorder or post-traumatic stress disorder. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing under the labeled conditions for use must evaluate the following: (i) The ability of the device to provide therapy for patients with sleep disturbance due to psychiatric conditions, using a validated measure; (ii) Worsening of any condition-specific symptoms using a validated measure for assessment of the particular condition; and (iii) Increase in symptoms of disturbed sleep or sleepiness using a validated measure. (2) Software must clearly describe all features and functions of the software implementing the digital therapy. Software verification, validation, and hazard analysis must also be provided. (3) The labeling must include the following: (i) Patient and physician labeling must include instructions for use, including images that demonstrate how to interact with the device; (ii) Patient and physician labeling must list the minimum operating system and general purpose computing requirements that support the software of the device; (iii) Patient and physician labeling must include a warning that the digital therapy device is not intended for use as a stand-alone therapeutic device; (iv) Patient and physician labeling must include a warning that the digital therapy device does not represent a substitution for the patient's medication; and (v) Physician labeling must include a summary of the clinical performance testing conducted with the device. |
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