21 CFR Part 882 — Neurological Devices

PART 882—NEUROLOGICAL DEVICES Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted. Editorial Note: Nomenclature changes to part 882 appear at 73 FR 35341, June 23, 2008. Subpart A—General Provisions § 882.1 Scope. (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.. [52 FR 17739, May 11, 1987, as amended at 68 FR 70436, Dec. 18, 2003; 78 FR 18233, Mar. 26, 2013] § 882.3 Effective dates of requirement for premarket approval. 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 PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution. [52 FR 17739, May 11, 1987] § 882.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 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), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a microorganism directly from clinical material; (7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma; (8) For noninvasive testing as defined in § 812.3(k) of this chapter; and (9) For near patient testing (point of care). [65 FR 2319, Jan. 14, 2000] Subpart B—Neurological Diagnostic Devices § 882.1020 Rigidity analyzer. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019] § 882.1030 Ataxiagraph. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 66 FR 46952, Sept. 10, 2001; 84 FR 71815, Dec. 30, 2019] § 882.1200 Two-point discriminator. (a) Identification. (b) Classification. [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] § 882.1240 Echoencephalograph. (a) Identification. (b) Classification. § 882.1275 Electroconductive media. (a) Identification. (b) Classification. § 882.1310 Cortical electrode. (a) Identification. (b) Classification. § 882.1320 Cutaneous electrode. (a) Identification. (b) Classification. § 882.1330 Depth electrode. (a) Identification. (b) Classification. § 882.1340 Nasopharyngeal electrode. (a) Identification. (b) Classification. § 882.1350 Needle electrode. (a) Identification. (b) Classification. § 882.1400 Electroencephalograph. (a) Identification. (b) Classification. § 882.1410 Electroencephalograph electrode/lead tester. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38807, July 25, 2001] § 882.1420 Electroencephalogram (EEG) signal spectrum analyzer. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 66 FR 46953, Sept. 10, 2001] § 882.1430 Electroencephalograph test signal generator. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001] § 882.1440 Neuropsychiatric interpretive electroencephalograph assessment aid. (a) Identification. (b) Classification. (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] § 882.1450 Brain injury adjunctive interpretive electroencephalograph assessment aid. (a) Identification. (b) Classification. (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., (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] § 882.1455 Traumatic brain injury eye movement assessment aid. (a) Identification. (b) Classification. (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; (C) Examples of screen displays and reports generated to provide the user results and normative data; (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] § 882.1460 Nystagmograph. (a) Identification. (b) Classification. § 882.1470 Computerized cognitive assessment aid. (a) Identification. (b) Classification. (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] § 882.1471 Computerized cognitive assessment aid for concussion. (a) Identification. (b) Classification. (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. (C) Construct validity of the device cognitive assessments. (D) A description of the normative database, which includes the following: ( 1 ( 2 ( 3 ( 4 ( 5 (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] § 882.1480 Neurological endoscope. (a) Identification. (b) Classification. § 882.1491 Pediatric Autism Spectrum Disorder diagnosis aid. (a) Identification. (b) Classification. (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. [87 FR 80445, Dec. 30, 2022] § 882.1500 Esthesiometer. (a) Identification. (b) Classification. [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] § 882.1525 Tuning fork. (a) Identification. (b) Classification. [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] § 882.1540 Galvanic skin response measurement device. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019] § 882.1550 Nerve conduction velocity measurement device. (a) Identification. (b) Classification. § 882.1560 Skin potential measurement device. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019] § 882.1561 Evoked photon image capture device. (a) Identification. (b) Classification. [81 FR 67155, Sept. 30, 2016] § 882.1565 Brain temperature measurement system. (a) Identification. (b) Classification. (1) In vivo performance testing must demonstrate that the device performs as intended for its anticipated conditions of use and can accurately and reliably measure brain temperature compared to a ground truth measurement. (2) Non-clinical performance testing must demonstrate that the device can accurately measure changes in brain temperature under simulated conditions of use. Testing must assess repeatability within pre- specified, clinically relevant parameters. The technical specifications of the device's hardware and software must be fully characterized. (3) Electrical safety, thermal safety, mechanical safety, and electromagnetic compatibility testing must be performed. (4) Software documentation must include a detailed technical description of the algorithm(s) used to generate the device output(s), and be accompanied by verification and validation testing to ensure device and algorithm functionality as informed by the software requirements and hazard analysis. (5) The tissue contacting device components must be demonstrated to be biocompatible. (6) Usability evaluation must demonstrate that the intended user(s) can safely and correctly use the device, based solely on reading the directions for use. (7) Labeling must include: (i) Instructions for use, including a detailed description of the device and explanation of all device outputs. (ii) The following warnings: (A) A statement that the device is not intended to measure core body temperature, and to use an independent thermometer to measure core body temperature. (B) Conditions of use that may impact the accuracy and reliability of the device measurement. (C) Conditions of use that may affect skin integrity or cause skin injury, such as extended wear duration or placement of the device on damaged or compromised skin, skin lesions, or open wounds. (D) Limitations of device use to inform diagnosis or therapy. (E) Summaries of in vivo testing conducted to demonstrate how the device functions as intended. (F) The summary must include the following: (G) A description of each device output. (H) A description of the study population and the use environment. (I) The methods used to collect temperature data. (J) Any observed adverse events and complications. [91 FR 23165, Apr. 30, 2026] § 882.1570 Powered direct-contact temperature measurement device. (a) Identification. (b) Classification. § 882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system. (a) Identification. (b) Classification. (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] § 882.1610 Alpha monitor. (a) Identification. (b) Classification. § 882.1620 Intracranial pressure monitoring device. (a) Identification. (b) Classification. § 882.1630 Cranial motion measurement device. (a) Identification. (b) Classification. (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] § 882.1700 Percussor. (a) Identification. (b) Classification. [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] § 882.1750 Pinwheel. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000] § 882.1790 Ocular plethysmograph. (a) Identification. (b) Classification. (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] § 882.1825 Rheoencephalograph. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, 1996] § 882.1835 Physiological signal amplifier. (a) Identification. (b) Classification. § 882.1845 Physiological signal conditioner. (a) Identification. (b) Classification. § 882.1855 Electroencephalogram (EEG) telemetry system. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 84 FR 71815, Dec. 30, 2019] § 882.1870 Evoked response electrical stimulator. (a) Identification. (b) Classification. § 882.1880 Evoked response mechanical stimulator. (a) Identification. (b) Classification. § 882.1890 Evoked response photic stimulator. (a) Identification. (b) Classification. § 882.1900 Evoked response auditory stimulator. (a) Identification. (b) Classification. § 882.1925 Ultrasonic scanner calibration test block. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, 2001] § 882.1935 Near Infrared (NIR) Brain Hematoma Detector. (a) Identification. (b) Classification. (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] § 882.1950 Tremor transducer. (a) Identification. (b) Classification. Subparts C-D [Reserved] Subpart E—Neurological Surgical Devices § 882.4030 Skull plate anvil. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38808, July 25, 2001] § 882.4060 Ventricular cannula. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000; 84 FR 71815, Dec. 30, 2019] § 882.4100 Ventricular catheter. (a) Identification. (b) Classification. § 882.4125 Neurosurgical chair. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] § 882.4150 Scalp clip. (a) Identification. (b) Classification. § 882.4175 Aneurysm clip applier. (a) Identification. (b) Classification. § 882.4190 Clip forming/cutting instrument. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994] § 882.4200 Clip removal instrument. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] § 882.4215 Clip rack. (a) Identification. (b) Classification. [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] § 882.4250 Cryogenic surgical device. (a) Identification. (b) Classification. § 882.4275 Dowel cutting instrument. (a) Identification. (b) Classification. § 882.4300 Manual cranial drills, burrs, trephines, and their accessories (a) Identification. (b) Classification. § 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories. (a) Identification. (b) Classification. § 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories. (a) Identification. (b) Classification. § 882.4325 Cranial drill handpiece (brace). (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, 2001] § 882.4360 Electric cranial drill motor. (a) Identification. (b) Classification. § 882.4370 Pneumatic cranial drill motor. (a) Identification. (b) Classification. § 882.4400 Radiofrequency lesion generator. (a) Identification. (b) Classification. § 882.4440 Neurosurgical headrests. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] § 882.4460 Neurosurgical head holder (skull clamp). (a) Identification. (b) Classification. § 882.4500 Cranioplasty material forming instrument. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] § 882.4525 Microsurgical instrument. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] § 882.4535 Nonpowered neurosurgical instrument. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] § 882.4545 Shunt system implantation instrument. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000; 84 FR 71815, Dec. 30, 2019] § 882.4560 Stereotaxic instrument. (a) Identification. (b) Classification. § 882.4565 Field generator positioning device. (a) Identification. (b) Classification. [90 FR 54234, Nov. 26, 2025] § 882.4600 Leukotome. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] § 882.4650 Neurosurgical suture needle. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000] § 882.4700 Neurosurgical paddie. (a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 69 FR 10332, Mar. 5, 2004] § 882.4725 Radiofrequency lesion probe. (a) Identification. (b) Classification. § 882.4750 Skull punch. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000] § 882.4800 Self-retaining retractor for neurosurgery. (a) Identification. (b) Classification. § 882.4840 Manual rongeur. (a) Identification. (b) Classification. § 882.4845 Powered rongeur. (a) Identification. (b) Classification. § 882.4900 Skullplate screwdriver. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] § 882.4950 Diagnostic neurosurgical microscope filter. (a) Identification. (b) Classification. (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. [86 FR 73973, Dec. 29, 2021] Subpart F—Neurological Therapeutic Devices § 882.5030 Methyl methacrylate for aneurysmorrhaphy. (a) Identification. (b) Classification. § 882.5050 Biofeedback device. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 63 FR 59229, Nov. 3, 1998] § 882.5060 Conditioning tool for eating disorders. (a) Identification. (b) Classification. (1) Nonclinical performance testing must demonstrate: (i) Device measurement accuracy and repeatability; and (ii) Device feedback accuracy. (2) Software verification, validation, and hazard analysis must be performed. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance testing must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device. (5) Labeling and patient labeling must be provided which includes the following: (i) Information identifying and explaining how to use the device and its components; and (ii) Information on how the device operates and the typical course of treatment. [86 FR 68403, Dec. 2, 2021] § 882.5070 Bite block. (a) Identification. (b) Classification. § 882.5150 Intravascular occluding catheter. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, 1996] § 882.5175 Carotid artery clamp. (a) Identification. (b) Classification. § 882.5200 Aneurysm clip. (a) Identification. (b) Classification. § 882.5225 Implanted malleable clip. (a) Identification. (b) Classification. § 882.5235 Aversive conditioning device. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 85 FR 13354, Mar. 6, 2020] § 882.5250 Burr hole cover. (a) Identification. (b) Classification. § 882.5275 Nerve cuff. (a) Identification. (b) Classification. § 882.5300 Methyl methacrylate for cranioplasty. (a) Identification. (b) Classification. § 882.5320 Preformed alterable cranioplasty plate. (a) Identification. (b) Classification. § 882.5330 Preformed nonalterable cranioplasty plate. (a) Identification. (b) Classification. § 882.5360 Cranioplasty plate fastener. (a) Identification. (b) Classification. § 882.5500 Lesion temperature monitor. (a) Identification. (b) Classification. § 882.5550 Central nervous system fluid shunt and components. (a) Identification. (b) Classification. § 882.5560 Cerebrospinal fluid shunt system. (a) Identification. (b) Classification. (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 hazards and special care associated with the use of the device; (v) A statement that the device is not to be reused, reprocessed, or resterilized when open but unused; and (vi) Cleaning instructions for the injection sites. [86 FR 73975, Dec. 29, 2021] § 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment. (a) Identification. (b) Classification. (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 include: (i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size. (ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature. (iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events. (iv) A shelf life. [81 FR 94253, Dec. 23, 2016] § 882.5700 Thermal system for insomnia. (a) Identification. (b) Classification. (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. [81 FR 44772, July 11, 2016] § 882.5705 Digital therapy device to reduce sleep disturbance for psychiatric conditions. (a) Identification. (b) Classification. (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. [88 FR 2223, Jan. 13, 2023] § 882.5800 Cranial electrotherapy stimulator. (a) Identification. (b) Classification. (i) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device to treat insomnia and/or anxiety. (ii) Components of the device that come into human contact must be demonstrated to be biocompatible. (iii) The device must be designed and tested for electrical safety and electromagnetic compatibility (EMC) in its intended use environment. (iv) Appropriate software verification, validation, and hazard analysis must be performed. (v) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge, and energy, must be fully characterized and verified. (vi) The labeling for the device must include the following: (A) The intended use population and the intended use environment; (B) A warning that patients should be monitored by their physician for signs of worsening; (C) A warning that instructs patients on how to mitigate the risk of headaches, and what to do should a headache occur; (D) A warning that instructs patients on how to mitigate the risk of dizziness, and what to do should dizziness occur; (E) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device; (F) Instructions for use that address where to place the electrodes, what stimulation parameters to use, and duration and frequency of treatment sessions. This information must be based on the results of clinical studies for the device; (G) A detailed summary of the device technical parameters, including waveform, output mode, pulse duration, frequency, train delivery, and maximum charge and energy; and (H) Information on validated methods for reprocessing any reusable components between uses. (vii) Cranial electrotherapy stimulator devices marketed prior to the effective date of this reclassification must have an amendment submitted to the previously cleared premarket notification (510(k)) demonstrating compliance with these special controls. (2) Class III (premarket approval) when intended to treat depression. (c) Date premarket approval application (PMA) or notice of completion of product development protocol (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 March 19, 2020, for any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 19, 2020, been found to be substantially equivalent to any cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other cranial electrotherapy stimulator device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. [84 FR 70013, Dec. 20, 2019] § 882.5801 Computerized behavioral therapy device for psychiatric disorders. (a) Identification. (b) Classification. (1) Clinical data must be provided to fulfill the following: (i) Describe a validated model of behavioral therapy for the psychiatric disorder; and (ii) Validate the model of behavioral therapy as implemented by the device. (2) Software 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. Software documentation must demonstrate that the device effectively implements the behavioral therapy model. (3) The following labeling must be provided: (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 compatible devices. (iii) Patient and physician labeling must include a warning that the device is not intended for use as a standalone therapy. (iv) Patient and physician labeling must include a warning that the device does not represent a substitution for the patient's medication. (v) Physician labeling must include a summary of the clinical testing with the device. [82 FR 61167, Dec. 27, 2017] § 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions. (a) Identification. (b) Classification. (1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety. (2) Software verification, validation, and hazard analysis must be performed. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) 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) Magnetic pulse output testing; (ii) Magnetic and electrical field testing; (iii) Testing of the safety features built into the device; and (iv) Testing of the sound levels patients are exposed to during device use. (5) The physician and patient labeling must include the following: (i) The risks and benefits associated with use of the device; (ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and (iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating. [84 FR 9230, Mar. 14, 2019] § 882.5803 Digital therapy device for Attention Deficit Hyperactivity Disorder. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate and document the following under the labeled conditions for use, which include considerations for the ability of the device to: (i) Use a validated measure to evaluate effectiveness of device to provide therapy for ADHD or any of its individual symptoms; and (ii) Capture all adverse events. (2) Software must be described and provided in a clear and detailed manner to include 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 items: (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 (OS) 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 standalone 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. [89 FR 71156, Sept. 3, 2024] § 882.5804 Computerized behavioral therapy device for the treatment of fibromyalgia symptoms. (a) Identification. (b) Classification. (1) Clinical data must demonstrate that the device performs as intended under the anticipated conditions of use and include the following: (i) Evaluation of improvement in the symptoms of fibromyalgia; and (ii) Evaluation of relevant adverse events. (2) Software verification, validation, and hazard analysis must demonstrate that the device performs as intended. (3) Physician and patient labeling must include the following: (i) Recommended treatment regimes, including frequency and duration of use; and (ii) A summary of the clinical data for the device, including a discussion of adverse events. [91 FR 38512, June 26, 2026] § 882.5805 Repetitive transcranial magnetic stimulation system. (a) Identification. (b) Classification. [76 FR 44491, July 26, 2011] § 882.5808 Transcranial magnetic stimulator for headache. (a) Identification. (b) Classification. (1) Appropriate analysis/testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety. (2) Appropriate verification, validation, and hazard analysis must be performed on the device software and firmware. (3) The elements of the device that contact the patient must be assessed to be biocompatible. (4) Non-clinical testing data must demonstrate that the device performs as intended under anticipated conditions of use. This includes full characterization of the magnetic pulse output and resulting magnetic field map. This also includes characterization of the sound level of the device during use. (5) Clinical testing must demonstrate that the device is safe and effective for treating headache in the indicated patient population. (6) The physician and patient labeling must include the following: (i) A summary of the clinical performance testing, including any adverse events and complications. (ii) The intended use population in terms of the types of headaches appropriate for use with the device. (iii) Information on how to report adverse events and device malfunctions. (iv) A diagram or picture depicting the proper placement of the device on the user. [78 FR 38458, July 8, 2014] § 882.5810 External functional neuromuscular stimulator. (a) Identification. (b) Classification. § 882.5820 Implanted cerebellar stimulator. (a) Identification. (b) Classification. (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. [44 FR 51730, Sept. 4, 1979, as amended at 49 FR 26574, June 28, 1984] § 882.5830 Implanted diaphragmatic/phrenic nerve stimulator. (a) Identification. (b) Classification. (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. [44 FR 51730, Sept. 4, 1979, as amended at 51 FR 12101, Apr. 8, 1986] § 882.5840 Implanted intracerebral/subcortical stimulator for pain relief. (a) Identification. (b) Classification. (c) Date premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required. [44 FR 51730, Sept. 4, 1979, as amended at 53 FR 48621, Dec. 1, 1988] § 882.5850 Implanted spinal cord stimulator for bladder evacuation. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of a PDP is required. [44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, 1996] § 882.5855 Brain stimulation programming planning software. (a) Identification. (b) Classification. (1) Software verification, validation, and hazard analysis must be performed. (2) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device. (3) Labeling must include: (i) The implanted brain stimulators for which the device is compatible. (ii) Instructions for use. (iii) Instructions and explanations of all user-interface components. (iv) A warning regarding use of the data with respect to not replacing clinical judgment. [88 FR 751, Jan. 5, 2023] § 882.5860 Implanted neuromuscular stimulator. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of PDP is required. [44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 64 FR 18329, Apr. 14, 1999] § 882.5870 Implanted peripheral nerve stimulator for pain relief. (a) Identification. (b) Classification. [44 FR 51730, Sept. 4, 1979, as amended at 78 FR 18234, Mar. 26, 2013] § 882.5880 Implanted spinal cord stimulator for pain relief. (a) Identification. (b) Classification. § 882.5887 External lower extremity nerve stimulator for Restless Legs Syndrome. (a) Identification. e.g., (b) Classification. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. This testing must include: (i) Characterization of the electrical stimulation parameters, including the following: waveforms; output modes; maximum output voltage and maximum output current (at 500Ω, 2kΩ, and 10kΩ loads); pulse duration; frequency; net charge per pulse; and maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω); (ii) Characterization of the therapy output across sudden and rapid changes in load impedance; and (iii) Characterization of electrode performance, including electrical performance, adhesive integrity, shelf life, reusability, and variation of impedance over the use of therapy. (2) The tissue-contacting components of the device must be demonstrated to be biocompatible. (3) Performance testing must demonstrate electrical, thermal, and mechanical safety along with electromagnetic compatibility of the device in the intended use environment. (4) Software verification, validation, and hazard analysis must be performed. (5) Physician and patient labeling must include the following: (i) Recommended treatment regimens, including frequency and duration of use, and identification of application site(s); (ii) Typical sensations experienced during treatment; (iii) Methods for identifying the appropriate stimulation intensity that is needed to reduce symptoms of Restless Legs Syndrome and is tolerable to patients; (iv) A shelf life for the electrode and reuse information; (v) Summaries of the electrical stimulation parameters and device technical parameters (including any wireless specifications); and (vi) Instructions on how to maintain the device, including all user-interface components. [91 FR 38510, June 26, 2026] § 882.5888 Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms. (a) Identification. (b) Classification. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. This testing must include: (i) Characterization of the electrical stimulation parameters, including the following: waveforms; output modes; maximum output voltage and maximum output current (at 500Ω, 2kΩ, and 10kΩ loads); pulse duration; frequency; net charge per pulse; maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω); (ii) Characterization of the impedance monitoring system; and (iii) Characterization of electrode performance, including the electrical performance, adhesive integrity, shelf life, reusability, and current distribution of the electrode surface area. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance testing must demonstrate electrical, thermal, and mechanical safety along with electromagnetic compatibility of the device in the intended use environment. (4) Software verification, validation, and hazard analysis must be performed. (5) Labeling must include the following: (i) Recommended treatment regimes, including but not limited to, frequency and duration of use, application site(s), and typical sensations experienced during treatment; (ii) A shelf life for the electrode and reuse information; (iii) Summaries of the electrical stimulation parameters and device technical parameters (including any wireless specifications); and (iv) Instructions on how to correctly use and maintain the device, including all user-interface components. [91 FR 31897, May 29, 2026] § 882.5889 Electrical tongue nerve stimulator to treat motor deficits. (a) Identification. (b) Classification. (1) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (2) Performance data must demonstrate the electromagnetic compatibility, battery safety, and electrical, mechanical, and thermal safety of the device. (3) Non-clinical performance testing must characterize the electrical stimulation parameters of the device. (4) Software verification, validation, and hazard analysis must be performed. Software documentation must include an assessment of the impact of threats and vulnerabilities on device functionality and end users as part of cybersecurity review. (5) Labeling must include: (i) A detailed summary of the device's technical parameters; (ii) Instructions for use; (iii) Cleaning, storage, and charging instructions; and (iv) Disposal instructions. [90 FR 59379, Dec. 19, 2025] § 882.5890 Transcutaneous electrical nerve stimulator for pain relief. (a) Identification. (b) Classification. § 882.5891 Transcutaneous electrical nerve stimulator to treat headache. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Appropriate analysis/testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety. (3) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (µC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm 2 2 (4) Electrical performance, adhesive integrity, shelf life, reusability, and current distribution testing of the electrodes must be conducted. (5) Appropriate software verification, validation, and hazard analysis must be performed. (6) Clinical performance data must demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population. (7) Labeling must include the following: (i) Appropriate contraindications such as not for use in subjects with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator. (ii) Appropriate warnings such as not to apply the device on the neck or chest, not to use the device in the presence of electronic monitoring equipment, not to use in the bath or shower, not to use while sleeping, not to use while driving, not to use while operating machinery. (iii) Appropriate precautions such as the long-term effects of chronic use of the device are unknown. (iv) A summary of the expected risks and benefits of using the device. (v) A summary of the clinical performance data, including information on the patient population for which the device has and has not been demonstrated to be effective, and any adverse events and complications. (vi) Information on how the device operates and the typical sensations experienced during treatment. (vii) A detailed summary of the device technical parameters. (viii) An expiration date/shelf life for the electrodes and the number of times they can be reused. (ix) Disposal instructions. [79 FR 37948, July 3, 2014] § 882.5892 External vagal nerve stimulator for headache. (a) Identification. (b) Classification. (1) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (µC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm 2 2 (2) Software verification, validation, and hazard analysis shall be performed. (3) Biocompatibility evaluation of the patient-contacting components of the device shall be performed. (4) The device shall be tested for electrical, thermal, and mechanical safety, and for electromagnetic compatibility (EMC). (5) The labeling must include: (i) Instructions for proper use of the device, including placement of the device on the patient; and (ii) Instructions on care and cleaning of the device. [82 FR 61169, Dec. 27, 2017] § 882.5893 Thermal vestibular stimulator for headache. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety. (3) The technical parameters of the device, including waveform outputs and temperature limits, must be identified. (4) Cleaning validation of earpieces must be conducted. (5) Software verification, validation, and hazard analysis must be performed. (6) Labeling must include the following: (i) Information on how the device operates and the typical sensations experienced during treatment; (ii) A detailed summary of the device's technical parameters; and (iii) Instructions for maintenance and cleaning of the device. [83 FR 52973, Oct. 19, 2018] § 882.5894 Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites. (a) Identification. (b) Classification. (1) Appropriate testing to characterize the electrical output specifications of the device ( i.e., (2) Mechanical bench testing must demonstrate that the device will withstand the labeled number duration of uses. (3) All elements of the device that may contact the patient must be assessed to be biocompatible. (4) Labeling must include: (i) Validated instructions which addresses the following: (A) Identification of areas of the body which are appropriate and not appropriate for contact with the device. (B) Whether use of the device in conjunction with flammable materials ( e.g., (C) Use of the device on or near implanted devices. (D) How to identify the correct type of skin condition. (ii) Technical parameters of the device (maximum output voltage (instantaneous), maximum output current (instantaneous), and pulse duration). (iii) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device. (iv) The anticipated number of device uses prior to failure. [80 FR 15165, Mar. 23, 2015] § 882.5895 Vibratory counter-stimulation device. (a) Identification. (b) Classification. (1) Appropriate analysis/testing must demonstrate electromagnetic compatibility (EMC), electrical safety, and thermal safety. (2) If the device contains software or firmware, appropriate verification, validation, and hazard analysis must be performed. (3) The elements of the device that contact the patient must be assessed to be biocompatible. (4) Non-clinical testing data (including vibration frequency, amplitude, and acceleration) must demonstrate that the device performs as intended under anticipated conditions of use. (5) Labeling must include: (i) Specific information pertinent to use of the device by the intended patient population and the treatment regimen; (ii) Warning to only use the device on normal, intact, clean, healthy skin; (iii) Warning to not use the device if the user has leg skin disorders, such as eczema, psoriasis, cellulitis, non-healing wounds; (iv) Warning to discontinue use if Restless Leg Syndrome symptoms worsen; and (v) Instructions for end users to contact the device manufacturer and MedWatch in case they experience any adverse events when using this device. [82 FR 13554, Mar. 14, 2017, as amended at 84 FR 71815, Dec. 30, 2019] § 882.5896 Percutaneous nerve stimulator for substance use disorders. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed. (3) Electrical performance testing of the device and electrodes must be conducted to validate the specified electrical output and duration of stimulation of the device. (4) Software verification, validation, and hazard analysis must be performed. (5) Sterility testing of the percutaneous components of the device must be performed. (6) Shelf life testing must be performed to demonstrate continued sterility, package integrity, and device functionality over the specified shelf life. (7) Labeling must include the following: (i) A detailed summary of the device technical parameters; (ii) A warning stating that the device is only for use on clean, intact skin; (iii) Instructions for use, including placement of the device on the patient; and (iv) A shelf life. [83 FR 5034, Feb. 5, 2018] § 882.5897 External upper limb tremor stimulator. (a) Identification. (b) Classification. (1) Non-clinical performance testing must assess the following: (i) Characterization of the electrical stimulation, including the following, must be performed: Waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density. (ii) Impedance testing, current distribution across the electrode surface area, adhesive integrity, and shelf life testing of the electrodes and gels must be conducted. (iii) Simulated use testing of sensor performance and the associated algorithms that determine the stimulation output must be conducted. (2) Patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance testing must demonstrate electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment. (4) Software verification, validation, and hazard analysis must be performed. (5) Physician and patient labeling must include: (i) Summaries of electrical stimulation parameters; (ii) Instructions on how to correctly use and maintain the device; (iii) Instructions and explanations of all user-interface components; (iv) Instructions on how to clean the device; (v) A shelf life for the electrodes and gel; and (vi) Reuse information. [83 FR 52316, Oct. 17, 2018] § 882.5898 Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder. (a) Identification. (b) Classification. (1) The patient-contacting components of the device must be demonstrated to be biocompatible. (2) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device. (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be performed: (i) Electrical performance testing must validate electrical output and duration of stimulation; (ii) Battery performance testing must be performed; and (iii) Adhesive integrity testing of the electrodes must be conducted. (4) The technical parameters of the device including waveform, maximum output current and voltage, pulse duration, frequency, net charge per pulse, maximum current density, maximum average current, and maximum average power density must be fully characterized. (5) Software verification, validation, and hazard analysis must be performed. (6) Shelf life testing of the electrodes must be performed to demonstrate continued package integrity and component functionality over the labeled shelf life. (7) Labeling must include the following: (i) A contraindication for patients with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator; (ii) A warning that the device is only for use on clean, intact skin; (iii) Information on how the device operates and the typical sensations experienced during treatment; (iv) A detailed summary of the device technical parameters; (v) A shelf life for the electrodes; (vi) Instructions for use, including placement of the device on the patient; and (vii) Cleaning instructions. [86 FR 70377, Dec. 10, 2021] § 882.5899 Trunk and limb electrical stimulator to treat headache. (a) Identification. (b) Classification. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. This testing must include: (i) Characterization of the electrical stimulation, including the following: Waveforms; output modes; maximum output voltage and maximum output current (at 500Ω, 2kΩ, and 10kΩ loads); pulse duration; frequency; net charge per pulse; and maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω); (ii) Characterization of the impedance monitoring system; and (iii) Characterization of the electrode performance including the electrical performance, adhesive integrity, shelf-life, reusability, and current distribution of the electrode surface area. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance testing must demonstrate electromagnetic compatibility and electrical, mechanical, and thermal safety in the intended use environment. (4) Software verification, validation, and hazard analysis must be performed. (5) Labeling must include the following: (i) Instructions for use, including the typical sensations experienced during treatment; (ii) A detailed summary of the electrical stimulation output, and the device technical parameters, including any wireless specifications; (iii) A shelf life for the electrodes and reuse information; and (iv) Instructions on care and cleaning of the device. [86 FR 68401, Dec. 2, 2021] § 882.5900 Preformed craniosynostosis strip. (a) Identification. (b) Classification. § 882.5910 Dura substitute. (a) Identification. (b) Classification. § 882.5940 Electroconvulsive therapy device. (a) Identification. (b) Classification. (i) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge and energy, and the type of impedance monitoring system must be fully characterized to ensure that the device performance characteristics are consistent with existing clinical performance data. (ii) Non-clinical testing data must confirm the electrical characteristics of the output waveform. (iii) Components of the device that come into human contact must be demonstrated to be biocompatible. (iv) Performance data must demonstrate electrical and mechanical safety and the functioning of all safety features built into the device including the static and dynamic impedance monitoring system. (v) Appropriate analysis/testing must validate electromagnetic compatibility. (vi) Appropriate software verification, validation, and hazard analysis must be performed. (vii) Performance data must demonstrate electrical performance, adhesive integrity, and physical and chemical stability of the stimulation electrodes. (viii) The labeling for the device must include the following: (A) Information related to generic adverse events associated with electroconvulsive therapy device (ECT) treatment; (B) Instructions must contain the following specific recommendations to the user of the device: ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 e.g., (C) Clinical training needed by users of the device; (D) Information on the patient population in which the device is intended to be used; (E) Information on how the device operates and the typical course of treatment; (F) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device; (G) A detailed summary of the device technical parameters; (H) Where appropriate, validated methods and instructions for reprocessing of any reusable components; (I) The following statement, prominently placed: “Warning: ECT device use may be associated with: disorientation, confusion, and memory problems”; and (J) Absent performance data demonstrating a beneficial effect of longer term use, generally considered treatment in excess of 3 months, the following statement, prominently placed: “Warning: When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated.” (ix) Patient labeling must be provided and include: (A) Relevant contraindications, warnings, precautions; (B) A summation of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device; (C) Information on how the device operates and the typical course of treatment; (D) The potential benefits; (E) Alternative treatments; (F) The following statement, prominently placed: “Warning: ECT device use may be associated with: Disorientation, confusion, and memory problems”; (G) Absent performance data demonstrating a beneficial effect of longer term use, generally considered treatment in excess of 3 months, the following statement, prominently placed: “Warning: When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated”; and (H) The following statements on known risks of ECT, absent performance data demonstrating that these risks do not apply: ( 1 i.e., ( 2 ( 3 ( i ( ii ( iii ( iv ( v ( vi ( vii (2) Classification: (i) Patients under 13 years or (ii) Patients 13 years and older who are not treatment-resistant or who do not require a rapid response due to the severity of their psychiatric or medical condition. (c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. [83 FR 66123, Dec. 26, 2018] § 882.5950 Neurovascular embolization device. (a) Identification. (b) Classification. [69 FR 77900, Dec. 29, 2004] § 882.5955 Temporary coil embolization assist device. (a) Identification. (b) Classification. (1) Clinical performance testing of the device must demonstrate the device performs as intended for temporary use as an endovascular device to assist in the coil embolization of intracranial aneurysms and must evaluate all adverse events, including tissue or vessel damage that could lead to dissection, perforation, hemorrhage, or vasospasm, thrombo-embolic events, and coil entanglement. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use, including: (i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, compressive, and tip deflection forces; (ii) Mechanical testing to evaluate the radial forces exerted by the device; (iii) Simulated use testing to demonstrate the device can be delivered to the target location in the neurovasculature and is compatible with embolic coils; (iv) Dimensional verification testing; (v) Radiopacity testing; and (vi) Performance testing to evaluate the coating integrity and particulates under simulated use conditions. (4) Animal testing under anticipated use conditions must evaluate all adverse events, including damage to vessels or tissues. (5) Performance data must support the sterility and pyrogenicity of the device. (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life. (7) The labeling must include: (i) Instructions for use; (ii) A detailed summary of the device technical parameters, including compatible delivery catheter dimensions and device sizing information; (iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events; and (iv) A shelf life. [86 FR 70733, Dec. 13, 2021] § 882.5960 Skull tongs for traction. (a) Identification. (b) Classification. § 882.5970 Cranial orthosis. (a) Identification. (b) Classification. [63 FR 40651, July 30, 1998]

Related documents

• 50 CFR Part 600 — Magnuson-Stevens Act Provisions#512148
• 50 CFR Part 622 — Fisheries of the Caribbean, Gulf of America, and South Atlantic#512149
• 50 CFR Part 635 — Atlantic Highly Migratory Species#512150
• 50 CFR Part 648 — Fisheries of the Northeastern United States#512151
• 50 CFR Part 660 — Fisheries off West Coast States#512152