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| [Code of Federal Regulations] |
| [Title 21, Volume 8] |
| [CITE: 21CFR874] |
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
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| PART 874 | EAR, NOSE, AND THROAT DEVICES |
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Subpart F - Therapeutic Devices
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Sec. 874.5220 Ear, nose, and throat drug administration device.
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(a) Identification. An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[51 FR 40389, Nov. 6, 1986, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38801, July 25, 2001]
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Sec. 874.5300 Ear, nose, and throat examination and treatment unit.
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(a) Identification. An ear, nose, and throat examination and treatment unit is an AC-powered device intended to support a patient during an otologic examination while providing specialized features for examination and treatment. The unit consists of a patient chair and table, drawers for equipment, suction and blowing apparatus, and receptacles for connection of specialized lights and examining instruments.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000]
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Sec. 874.5350 Suction antichoke device.
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(a) Identification. A suction antichoke device is a device intended to be used in an emergency situation to remove, by the application of suction, foreign objects that obstruct a patient's airway to prevent asphyxiation to the patient.
(b) Classification. Class III.
(c) Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP for a device is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any suction antichoke device that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to a suction antichoke device that was in commercial distribution before May 28, 1976. Any other suction antichoke device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
[51 FR 40389, Nov. 6, 1986, as amended at 64 FR 18329, Apr. 14, 1999; 65 FR 2316, Jan. 14, 2000]
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Sec. 874.5370 Tongs antichoke device.
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(a) Identification. A tongs antichoke device is a device that is intended to be used in an emergency situation to grasp and remove foreign objects that obstruct a patient's airway to prevent asphyxiation of the patient. This generic type of device includes a plastic instrument with serrated ends that is inserted into the airway in a blind manner to grasp and extract foreign objects, and a stainless steel forceps with spoon ends that is inserted under tactile guidance to grasp and extract foreign objects from the airway.
(b) Classification. Class III.
(c) Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP for a device is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any tongs antichoke device that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to a tongs antichoke device that was in commercial distribution before May 28, 1976. Any other tongs antichoke device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
[51 FR 40389, Nov. 6, 1986, as amended at 64 FR 18329, Apr. 14, 1999]
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Sec. 874.5550 Powered nasal irrigator.
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(a) Identification. A powered nasal irrigator is an AC-powered device intended to wash the nasal cavity by means of a pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
[55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000]
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Sec. 874.5800 External nasal splint.
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(a) Identification. An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
[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]
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Sec. 874.5840 Antistammering device.
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(a) Identification. An antistammering device is a device that electronically generates a noise when activated or when it senses the user's speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's involuntary hesitative or repetitive speech.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000]
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Sec. 874.5900 External upper esophageal sphincter compression device.
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(a) Identification. An external upper esophageal sphincter compression device is a prescription device used to apply external pressure on the cricoid cartilage for the purpose of reducing the symptoms of laryngopharyngeal reflux disease.
(b) Classification. Class II (special controls). The special controls for this device are:
(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., tensile strength testing, fatigue testing) and
(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]
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Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.
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