PART 874—EAR, NOSE, AND THROAT DEVICES Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted. Editorial Note: Nomenclature changes to part 874 appear at 73 FR 35341, June 23, 2008. Subpart A—General Provisions § 874.1 Scope. (a) This part sets forth the classification of ear, nose, and throat 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 cannot show merely that the device is accurately described by the section title and identification provision 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, an ear, nose, and throat device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed in one subpart only. (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.. [51 FR 40389, Nov. 6, 1986, as amended at 67 FR 67790, Nov. 7, 2002; 78 FR 18233, Mar. 26, 2013] § 874.3 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 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. § 874.9 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 2315, Jan. 14, 2000] Subpart B—Diagnostic Devices § 874.1050 Audiometer. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 64 FR 14831, Mar. 29, 1999] § 874.1060 Acoustic chamber for audiometric testing. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38800, July 25, 2001] § 874.1070 Short increment sensitivity index (SISI) adapter. (a) Identification. (b) Classification. [55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2315, Jan. 14, 2000] § 874.1080 Audiometer calibration set. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38800, July 25, 2001] § 874.1090 Auditory impedance tester. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019] § 874.1100 Earphone cushion for audiometric testing. (a) Identification. (b) Classification. [51 FR 40389, Nov. 9, 1986; 52 FR 18495, May 15, 1987, as amended at 52 FR 32111, Aug. 25, 1987; 65 FR 2315, Jan. 14, 2000] § 874.1120 Electronic noise generator for audiometric testing. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019] § 874.1325 Electroglottograph. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019] § 874.1500 Gustometer. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000; 90 FR 55985, Dec. 4, 2025] § 874.1600 Olfactory test device. (a) Identification. (b) Classification. [71 FR 32835, June 7, 2006] § 874.1800 Air or water caloric stimulator. (a) Identification. (b) Classification. [55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000] § 874.1820 Surgical nerve stimulator/locator. (a) Identification. (b) Classification. § 874.1925 Toynbee diagnostic tube. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000] Subpart C [Reserved] Subpart D—Prosthetic Devices § 874.3300 Air-conduction hearing aid. (a) Identification. (b) Classification. [87 FR 50762, Aug. 17, 2022] § 874.3302 Bone-conduction hearing aid. (a) Identification. (b) Classification. [87 FR 50762, Aug. 17, 2022] § 874.3305 Wireless air-conduction hearing aid. (a) Identification. (b) Classification. (1) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device; (2) Performance testing must validate safety of exposure to non-ionizing radiation; and (3) Performance data must validate wireless technology functions. (c) Premarket notification. [76 FR 34846, June 15, 2011, as amended at 87 FR 50762, Aug. 17, 2022] § 874.3310 Hearing aid calibrator and analysis system. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019] § 874.3315 Tympanic membrane contact hearing aid. (a) Identification. (b) Classification. (1) The patient contacting components must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, and must include: (i) Mechanical integrity testing; (ii) Electrical and thermal safety testing; (iii) Software verification, validation, and hazard analysis; (iv) Reliability testing consistent with expected device life; (v) Electromagnetic compatibility testing; and (vi) Validation testing of device output and mechanical force applied to the tympanic membrane in a clinically appropriate model. (3) Clinical performance testing must characterize any adverse events observed during clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. (4) Professional training must include the ear impression procedure, correct placement, fitting, monitoring, care, and maintenance of the device. (5) Labeling must include the following: (i) A detailed summary of the adverse events and effectiveness outcomes from the clinical performance testing; (ii) Detailed instructions on how to fit the device to the patient; (iii) Instructions for periodic cleaning of any reusable components; (iv) Information related to electromagnetic compatibility; and (v) Patient labeling that includes: (A) A patient card that identifies if a patient has been fitted with any non-self- removable components of the device and provides relevant information in cases of emergency; (B) Information on how to correctly use and maintain the device; (C) The potential risks and benefits associated with the use of the device; and (D) Alternative treatments. [81 FR 3326, Jan. 21, 2015, as amended at 87 FR 50762, Aug. 17, 2022] § 874.3320 Group hearing aid or group auditory trainer. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019] § 874.3325 Self-fitting air-conduction hearing aid. (a) Identification. (b) Classification. (1) Clinical data must evaluate the effectiveness of the self-fitting strategy. (2) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested. (3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device. (4) Software verification, validation, and hazard analysis must be performed. (5) If the device incorporates wireless technology: (i) Performance testing must validate safety of exposure to non-ionizing radiation; and (ii) Performance data must validate wireless technology functions. (6) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use. [84 FR 57612, Oct. 28, 2019, as amended at 87 FR 50762, Aug. 17, 2022] § 874.3330 Master hearing aid. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019] § 874.3340 Active implantable bone conduction hearing system. (a) Identification. (b) Classification. (1) Clinical performance testing must characterize any adverse events observed during implantation and clinical use, and must also demonstrate that the device performs as intended under anticipated conditions of use. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Performance data must validate force output in a clinically relevant model. (ii) Impact testing in a clinically relevant anatomic model must be performed. (iii) Mechanical integrity testing must be performed. (iv) Reliability testing consistent with expected device life must be performed. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of the patient-contacting components of the device. (5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (6) Performance data must demonstrate the wireless compatibility, electromagnetic compatibility, and electrical safety of the device. (7) Software verification, validation, and hazard analysis must be performed. (8) Labeling must include: (i) A summary of clinical testing conducted with the device that includes a summary of device-related complications and adverse events; (ii) Instructions for use; (iii) A surgical guide for implantation, which includes instructions for imaging to assess bone dimensions; (iv) A shelf life, for device components provided sterile; (v) A patient identification card; and (vi) A patient user manual. [83 FR 54009, Oct. 26, 2018] § 874.3375 Battery-powered artificial larynx. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, 2001] § 874.3400 Tinnitus masker. (a) Identification. (b) Classification. (1) Hearing health care professional diagnosis, fitting of the device, and followup care, (2) Risks, (3) Benefits, (4) Warnings for safe use, and (5) Specifications. [51 FR 40389, Nov. 6, 1986, as amended at 65 FR 17145, Mar. 31, 2000] § 874.3410 Combined acoustic and electrical external stimulation device for the relief of tinnitus. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate performance as intended under anticipated conditions for use including the following: (i) Evaluation of tinnitus symptoms using a validated method; and (ii) Evaluation of all adverse events. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Verification of specified electrical stimulation parameters; and (ii) Verification of specified acoustic stimulation parameters, including maximum output limits, distortion levels, and frequency response. (3) Performance data must demonstrate the electromagnetic compatibility, battery safety, and electrical safety of the device. (4) Software verification, validation, and hazard analysis must be performed. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Human factors testing must demonstrate that users can successfully use the device in the intended use environment based solely on its labeling and instructions for use. (7) Labeling must include the following: (i) A statement that the device is intended to be prescribed by a healthcare professional with expertise in the evaluation and management of tinnitus; (ii) Information regarding emotional, psychological, and physical considerations for patient selection; and (iii) Device specifications, including the materials of patient-contacting components of the device, electrical output waveform, stimulation peak voltage and current, pulse duration, frequency, maximum current density, maximum phase charge, and power source. [91 FR 35140, June 10, 2026] § 874.3430 Middle ear mold. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019] § 874.3450 Partial ossicular replacement prosthesis. (a) Identification. (b) Classification. § 874.3495 Total ossicular replacement prosthesis. (a) Identification. (b) Classification. § 874.3540 Prosthesis modification instrument for ossicular replacement surgery. (a) Identification. TM (b) Classification. [51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 65 FR 2316, Jan. 14, 2000; 90 FR 55985, Dec. 4, 2025] § 874.3620 Ear, nose, and throat synthetic polymer material. (a) Identification. (b) Classification. § 874.3695 Mandibular implant facial prosthesis. (a) Identification. (b) Classification. § 874.3730 Laryngeal prosthesis (Taub design). (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019] § 874.3760 Sacculotomy tack (Cody tack) (a) Identification. (b) Classification. § 874.3820 Endolymphatic shunt. (a) Identification. (b) Classification. § 874.3850 Endolymphatic shunt tube with valve. (a) Identification. (b) Classification. [67 FR 20894, Apr. 29, 2002] § 874.3880 Tympanostomy tube. (a) Identification. (b) Classification. § 874.3900 Nasal dilator. (a) Identification. (b) Classification. [64 FR 10949, Mar. 8, 1999] § 874.3930 Tympanostomy tube with semipermeable membrane. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 65 FR 17145, Mar. 31, 2000] § 874.3950 Transcutaneous air conduction hearing aid system. (a) Identification. (b) Classification. [67 FR 67790, Nov. 7, 2002, as amended at 87 FR 50762, Aug. 17, 2022] Subpart E—Surgical Devices § 874.4100 Epistaxis balloon. (a) Identification. (b) Classification [51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000] § 874.4140 Ear, nose, and throat bur. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38800, July 25, 2001] § 874.4175 Nasopharyngeal catheter. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, 2001] § 874.4180 Eustachian tube balloon dilation system. (a) Identification. (b) Classification. (1) 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) Mechanical testing, including tensile and flexural testing of catheter joints and materials. (ii) Durability testing, including fatigue and burst pressure testing of the balloon materials and components. (iii) Inflation and deflation characterization testing, including time and pressure measurements, and leak testing of the balloon. (iv) Verification testing of safety features built into the device must be performed, including the characterization of catheter geometries and distal tip insertion limitation mechanisms. (2) Simulated use testing in a clinically relevant model must demonstrate the reliability of the device to remain mechanically functional throughout the anticipated conditions of use, and validate that the design features limit access to only the cartilaginous portion of the Eustachian tube. (3) The patient-contacting components of the device must be demonstrated to be biocompatible. (4) Performance data must demonstrate the sterility of the device. (5) Performance data must support shelf life by demonstrating continued sterility of the device, package integrity, and device functionality over the identified shelf life. (6) Training must include simulated use on cadavers to ensure users can follow the instructions for use to allow safe use of the device. (7) Labeling must include: (i) Detailed instructions for use. (ii) A detailed summary of the device technical parameters, including maximum allowed inflation pressure, allowable catheter geometries, and available balloon sizes. (iii) A shelf life. [81 FR 73041, Oct. 24, 2016] § 874.4250 Ear, nose, and throat electric or pneumatic surgical drill. (a) Identification. (b) Classification. § 874.4350 Ear, nose, and throat fiberoptic light source and carrier. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, 2001] § 874.4420 Ear, nose, and throat manual surgical instrument. (a) Identification. (b) Classification [51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 65 FR 2316, Jan. 14, 2000; 72 FR 17400, Apr. 9, 2007] § 874.4450 Powered insertion system for a cochlear implant electrode array. (a) Identification. (b) Classification. (1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including evaluation of all adverse events. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include: (i) Verification of cochlear implant attachment force, release force, and insertion speed; (ii) Testing to demonstrate the device does not damage or degrade the cochlear implant (including the lead and array portions of the cochlear implant); and (iii) Comparison testing with manual insertion to evaluate: (A) Differences in cochlear implant array insertion force associated with use of the device; and (B) Intracochlear placement of the cochlear implant array (intended scala placement and array insertion depth, together with minimal array tip foldover and cochlear scala translocation). (3) Usability testing in a simulated hospital environment with an anatomically relevant model ( e.g., (i) Successful use to aid in placement of the electrode array into the cochlea; and (ii) Harms caused by use errors observed. (4) Changes in cochlear implant compatibility are determined to significantly affect the safety or effectiveness of the device and must be validated through performance testing or a rationale for omission of any testing. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device. (7) The patient-contacting components of the device must be demonstrated to be sterile and non-pyrogenic. (8) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life. (9) Software verification, validation, and hazard analysis must be performed for any software components of the device. (10) Labeling must include: (i) The recommended training for the safe use of the device; (ii) Summary of the relevant clinical and non-clinical testing pertinent to use of the device with compatible electrode arrays; and (iii) A shelf life. [88 FR 979, Jan. 6, 2023] § 874.4460 Cooperative powered surgical assist device for ENT surgery. (a) Identification. (b) Classification. (1) Simulated-use testing must demonstrate that the device performs as intended under anticipated conditions of use to successfully assist in the indicated surgery, including: (i) Testing in a simulated hospital environment with an anatomically relevant model; (ii) Compatibility testing of all indicated instruments; (iii) Human factors/usability evaluation; and (iv) Validation of device use by surgeons, including: (A) The user interface and controller(s); (B) Compatibility with the ranges of surgeon-applied forces, torques, speeds, and motion; and (C) Time required for emergency removal of the device and associated instruments in the event of power loss or device failure. (2) Non-clinical performance testing must demonstrate hardware and system verification, including verification of critical parameters (including minimum and maximum forces, torques, speeds, and range of motion). (3) Software verification, validation, and hazard analysis must be performed for any software components of the device. (4) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device. (5) All parts or components of the device that enter the sterile field must be demonstrated to be sterile. (6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life. (7) All patient-contacting components of the device must be demonstrated to be biocompatible. (8) Labeling must include: (i) Identification of compatible instruments; (ii) A statement about any training needed prior to use of the device; (iii) A summary of all relevant performance testing, including simulated-use testing; and (iv) Reprocessing instructions for reusable device components. [91 FR 57504, Sept. 10, 2026] § 874.4490 Argon laser for otology, rhinology, and laryngology. (a) Identification. (b) Classification. [58 FR 29534, May 21, 1993] § 874.4500 Ear, nose, and throat microsurgical carbon dioxide laser. (a) Identification. (b) Classification. § 874.4680 Bronchoscope (flexible or rigid) and accessories. (a) Identification. (b) Classification. § 874.4710 Esophagoscope (flexible or rigid) and accessories. (a) Identification. (b) Classification. § 874.4720 Mediastinoscope and accessories. (a) Identification. (b) Classification. § 874.4750 Laryngostroboscope. (a) Identification. (b) Classification. [55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38801, July 25, 2001] § 874.4760 Nasopharyngoscope (flexible or rigid) and accessories. (a) Identification. (b) Classification. § 874.4770 Otoscope. (a) Identification. (b) Classification. [55 FR 48440, Nov. 20, 1990, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, 2001] § 874.4780 Intranasal splint. (a) Identification. (b) Classification. [64 FR 10949, Mar. 8, 1999] § 874.4800 Bone particle collector. (a) Identification. (b) Classification. [64 FR 10949, Mar. 8, 1999] Subpart F—Therapeutic Devices § 874.5220 Ear, nose, and throat drug administration device. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38801, July 25, 2001;90 FR 55985, Dec. 4, 2025 ] § 874.5300 Ear, nose, and throat examination and treatment unit. (a) Identification. (b) Classification. [55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000] § 874.5350 Suction antichoke device. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of PDP is required. [51 FR 40389, Nov. 6, 1986, as amended at 64 FR 18329, Apr. 14, 1999; 65 FR 2316, Jan. 14, 2000] § 874.5370 Tongs antichoke device. (a) Identification. (b) Classification. (c) Date PMA or notice of completion of PDP is required. [51 FR 40389, Nov. 6, 1986, as amended at 64 FR 18329, Apr. 14, 1999] § 874.5550 Powered nasal irrigator. (a) Identification. (b) Classification. [55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000] § 874.5800 External nasal splint. (a) Identification. (b) Classification. [51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 59 FR 63009, Dec. 7, 1994; 66 FR 38801, July 25, 2001] § 874.5840 Antistammering device. (a) Identification. (b) Classification. [51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000] § 874.5900 External upper esophageal sphincter compression device. (a) Identification. (b) Classification. (1) The patient contacting components must be demonstrated to be biocompatible. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated: (i) Mechanical integrity testing ( e.g., (ii) Shelf life testing. (3) The technical specifications must include pressure measurement accuracy to characterize device performance. (4) Clinical performance testing must document any adverse events observed during clinical use, and demonstrate that the device performs as intended under anticipated conditions of use. (5) Labeling must include the following: (i) Appropriate warnings and precautions, (ii) A detailed summary of the clinical testing pertinent to use of the device including a detailed summary of the device-related complications or adverse events, (iii) Detailed instructions on how to fit the device to the patient, and (iv) Instructions for reprocessing of any reusable components. (6) Patient labeling must be provided and must include: (i) Relevant warnings, precautions, and adverse effects/complications, (ii) Information on how to correctly wear the device, (iii) The potential risks and benefits associated with the use of the device, (iv) Alternative treatments, and (v) Reprocessing instructions. [80 FR 46194, Aug. 4, 2015] § 874.5950 Oropharyngeal electrical stimulator. (a) Identification. (b) Classification. (1) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use, including the following: (i) Electrical output testing; (ii) Mechanical integrity testing of electrical components; (iii) Testing to verify safe use of the electrical stimulator component in the presence of supplementary oxygen; and (iv) If the device incorporates a feeding tube, feeding tube functionality testing, including mechanical integrity, liquid leakage, flow rate and connector compatibility. (2) The patient-contacting components of the device must be demonstrated to be biocompatible. (3) Performance testing must demonstrate the sterility of the components intended to be provided sterile. (4) Performance data must validate the reprocessing instructions for any reusable components of the device. (5) Performance testing must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life. (6) Software verification, validation and hazard analysis must be performed for any software components of the device. (7) Performance testing must demonstrate the electromagnetic compatibility and electrical safety of any electrical components. (8) A training program must be included with sufficient educational elements so that upon completion of the training program, the user can correctly operate the device. (9) Usability testing must demonstrate that the device can be correctly used as per training and labeling. (10) The labeling must include a shelf life for any sterile components. [91 FR 32346, June 1, 2026] § 874.6000 Transcutaneous electrical nerve stimulator for the relief of congestion. (a) Identification. (b) Classification. (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including electrical stimulation parameters that must be specified and verified. (2) Performance data must demonstrate the electromagnetic compatibility, battery safety, and electrical safety of the device. (3) Software verification, validation, and hazard analysis must be performed. (4) The patient-contacting components of the device must be demonstrated to be biocompatible. (5) Human factors testing must demonstrate that users can successfully use the device in the intended use environment based solely on its labeling and instructions for use. (6) Labeling must include the following: (i) Instructions for use, including images that demonstrate how to use the device; (ii) Device specifications, including the number of channels, output waveform, stimulation peak voltage and current, pulse duration, frequency, maximum current density, maximum phase charge, and power source; and (iii) Explanations of the user-interface components. [91 FR 20350, Apr. 16, 2026]