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(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 8 872.9. (52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 65 FR 2315, Jan. 14, 2000)

records, and $820.198, with respect to complaint files. (52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989)

8872.6475 Heat source for bleaching

teeth. (a) Identification. A heat source for bleaching teeth is an AC-powered device that consists of a light or an electric heater intended to apply heat to a tooth after it is treated with a bleaching agent.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994)

$ 872.6640 Dental operative unit and

accessories. (a) Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

(b) Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to $ 872.9. [55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 65 FR 2315, Jan. 14. 2000]

$ 872.6510 Oral irrigation unit.

(a) Identification. An oral irrigation unit is an AC-powered device intended to provide a pressurized stream of water to remove food particles from between the teeth and promote good periodontal (gum) condition.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994)

8872.6570 Impression tube.

(a) Identification. An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth. The hollow tube is filled with impression material. One end of the tube is sealed with a softened material, such as wax, the remaining end is slipped over the tooth to make the impression.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exceptions of 8820.180, with respect to general requirements concerning

$ 872.6650 Massaging pick or tip for

oral hygiene. (a) Identification. A massaging pick or tip for oral hygiene is a rigid, pointed device intended to be used manually to stimulate and massage the gums to promote good periodontal (gum) condition.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exceptions of $820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files. (52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989)

8872.6660 Porcelain powder for clin.

ical use. (a) Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

(b) Classification. Class II.

heat sterilizer that was in commercial distribution before May 28, 1976, or that has on or before April 21, 1997, been found to be substantially equivalent to the endodontic dry heat sterilizer that was in commercial distribution before May 28, 1976. Any other endodontic dry heat sterilizer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

(52 FR 30097, Aug. 12, 1987, as amended at 62 FR 2902, Jan. 21, 1997; 62 FR 31512, June 10, 1997]

$ 872.6670 Silicate protector.

(a) Identification. A silicate protector is a device made of silicone intended to be applied with an absorbent tipped applicator to the surface of a new restoration to exclude temporarily fluids from its surface.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exceptions of $ 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files. (52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989)

$ 872.6770 Cartridge syringe.

(a) Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.

(b) Classification. Class II.

8 872.6710 Boiling water sterilizer.

(a) Identification. A boiling water sterilizer is an AC-powered device that consists of a container for boiling water. The device is intended to sterilize dental and surgical instruments by submersion in the boiling water in the container.

(b) Classification. Class I. (55 FR 48439, Nov. 20, 1990]

$ 872.6730 Endodontic dry heat steri

lizer. (a) Identification. An endodontic dry heat sterilizer is a device intended to sterilize endodontic and other dental instruments by the application of dry heat. The heat is supplied through glass beads which have been heated by electricity.

(b) Classification. Class III.

(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 April 21, 1997, for any endodontic dry

8872.6855 Manual toothbrush.

(a) Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exceptions of $820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files. (52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989)

8872.6865 Powered toothbrush.

(a) Identification. A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994)

8872.6890 Intraoral dental wax.

(a) Identification. Intraoral dental wax is a device made of wax intended to construct patterns from which custom made metal dental prostheses, such as crowns and bridges, are cast. In orthodontic dentistry, the device is intended to make a pattern of a patient's bite to make study models of the teeth.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations 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. (52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994)

PART 874-EAR, NOSE, AND

THROAT DEVICES

Subpart A-General Provisions

Sec. 874.1 Scope. 874.3 Effective dates of requirement for pre

market approval. 874.9 Limitations of exemptions from sec

tion 510(k) of the Federal Food, Drug. and Cosmetic Act (the act).

$872.6870 Disposable flouride tray.

(a) Identification. A disposable fluoride tray is a device made of styrofoam intended to apply fluoride topically to the teeth. To use the tray, the patient bites down on the tray which has been filled with a fluoride solution.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exceptions of $820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files. (52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5, 1989) $ 872.6880 Preformed impression tray.

(a) Identification. A preformed impression tray is a metal or plastic device intended to hold impression material, such as alginate, to make an impression of a patient's teeth or alveolar process (bony tooth sockets) to reproduce the structure of a patient's teeth and gums.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exceptions of $820.180, with respect to general requirements concerning records, and $820.198, with respect to complaint files. (52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13832, Apr. 5, 1989)

Subpart B-Diagnostic Devices

874.1050 Audiometer. 874.1060 Acoustic chamber for audiometric

testing. 874.1070 Short increment sensitivity index

(SISI) adapter. 874.1080 Audiometer calibration set. 874.1090 Auditory impedance tester. 874.1100 Earphone cushion for audiometric

testing. 874.1120 Electronic noise generator

for audiometric testing. 874.1325 Electroglottograph. 874.1500 Gustometer. 874.1800 Air or water caloric stimulator. 874.1820 Surgical nerve stimulator locator. 874.1925 Toynbee diagnostic tube.

Subpart C [Reserved)

Subpart D-Prosthetic Devices

874.3300 Hearing aid. 874.3310 Hearing aid calibrator and analysis

system.

SOURCE: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

Subpart A-General Provisions

874.3320 Group hearing aid or group audi

tory trainer. 874.3330 Master hearing aid. 874.3375 Battery-powered artificial larynx. 874.3400 Tinnitus masker. 874.3430 Middle ear mold. 874.3450 Partial ossicular replacement pros

thesis. 874.3495 Total ossicular replacement pros

thesis. 874.3540 Prosthesis modification instrument

for ossicular replacement surgery. 874.3620 Ear, nose, and throat synthetic

polymer material. 874.3695 Mandibular implant facial pros

thesis. 874.3730 Laryngeal prosthesis (Taub design). 874.3760 Sacculotomy tack (Cody tack). 874.3820 Endolymphatic shunt. 874.3850 Endolymphatic shunt tube with

valve. 874.3880 Tympanostomy tube. 874.3900 Nasal dilator. 874.3930 Tympanostomy tube with

semipermeable membrane.

a

Subpart E-Surgical Devices 874.4100 Epistaxis balloon. 874.4140 Ear, nose, and throat bur. 874.4175 Nasopharyngeal catheter. 874.4250 Ear, nose, and throat electric or

pneumatic surgical drill. 874.4350 Ear, nose, and throat fiberoptic

light source and carrier. 874.4420 Ear, nose, and throat manual sur

gical instrument. 874.4490 Argon laser for otology, rhinology,

and laryngology. 874.4500 Ear, nose, and throat microsurgical

carbon dioxide laser. 874.4680 Bronchoscope (flexible or rigid) and

accessories. 874.4710 Esophagoscope (flexible or rigid)

and accessories. 874.4720 Mediastinoscope and accessories. 874.4750 Laryngostroboscope. 874.4760 Nasopharyngoscope (flexible or

rigid) and accessories. 874.4770 Otoscope. 874.4780 Intranasal splint. 874.4800 Bone particle collector.

8874.1 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 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. $ 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 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

an

Subpart F-Therapeutic Devices 874.5220 Ear, nose, and throat drug adminis

tration device. 874.5300 Ear, nose, and throat examination

and treatment unit. 874.5350 Suction antichoke device. 874.5370 Tongs antichoke device. 874.5550 Powered nasal irrigator. 874.5800 External nasal splint. 874.5840 Antistammering device.

AUTHORITY: 21 U.S.C. 351, 360, 3600, 360e, 360j, 371.

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.

a

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 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

a surrogate marker for screening, diagnosis, 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;

serves

as

or

8874.9 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

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