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vessels that come into physical contact with gametes, embryos or tissue culture media.

(b) Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing).

mation, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). $ 884.6190 Assisted reproductive mi.

croscopes and microscope acces

sories. (a) Identification. Assisted reproduction microscopes and microscope accessories (excluding microscope stage warmers, which are classified under assisted reproduction accessories) are optical instruments used to enlarge images of gametes or embryos. Variations of microscopes and accessories used for these purposes would include phase contrast microscopes, dissecting microscopes and inverted stage microscopes.

(b) Classification. Class 1. This device is exempt from the premarket notification procedures in subpart E of part 807 of chapter subject to limitation in $ 884.9. (63 FR 48436, Sept. 10, 1998, as amended at 64 FR 62977, Nov. 18, 1999)

PART 886-OPHTHALMIC DEVICES

Subpart A-General Provisions

8884.6170 Assisted reproduction water

and water purification systems. (a) Identification. Assisted reproduction water purification systems are devices specifically intended to generate high quality, sterile, pyrogen-free water for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction procedures. These devices may also be intended as the final rinse for labware or other assisted reproduction devices that will contact the gametes or embryos. These devices also include bottled water ready for reconstitution available from a vendor that is specifically intended for reconstitution of media used for aspiration, incubation, transfer, or storage of gametes or embryos for IVF or other assisted reproduction procedures.

(b) Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, water quality testing, design specifications, labeling requirements, biocompatibility testing, and clinical testing). 8884.6180 Reproductive media and

supplements. (a) Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).

(b) Classification. Class II (special controls) (mouse embryo assay infor

Sec. 886.1 Scope. 886.3 Effective dates of requirement for pre

market approval. 886.9 Limitations of exemptions from sec

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

Subpart B-Diagnostic Devices

886.1040 Ocular esthesiometer. 886.1050 Adaptometer (biophotometer). 886.1070 Anomaloscope. 886.1090 Haidlinger brush. 886.1120 Ophthalmic camera. 886.1140 Ophthalmic chair. 886.1150 Visual acuity chart. 886.1160 Color vision plate illuminator. 886.1170 Color vision tester. 886.1190 Distometer. 886.1200 Optokinetic drum. 886.1220 Corneal electrode. 886.1250 Euthyscope. 886.1270 Exophthalmometer. 886.1290 Fixation device. 886.1300 Afterimage flasher. 886.1320 Fornixscope. 886.1330 Amsler grid. 886.1340 Haploscope. 886.1350 Keratoscope. 886.1360 Visual field laser instrument.

886.1375 Bagolini lens. 886.1380 Diagnostic condensing lens. 886.1385 Polymethylmethacrylate (PMMA)

diagnostic contact lens. 886.1390 Flexible diagnostic Fresnel lens. 886.1395 Diagnostic Hruby fundus lens. 886.1400 Maddox lens. 886.1405 Ophthalmic trial lens set. 886.1410 Ophthalmic trial lens clip. 886.1415 Ophthalmic trial lens frame. 886.1420 Ophthalmic lens gauge. 886.1425 Lens measuring instrument. 886.1430 Ophthalmic contact lens radius

measuring device. 886.1435 Maxwell spot. 886.1450 Corneal radius measuring device. 886.1460 Stereopsis measuring instrument. 886.1500 Headband mirror. 886.1510 Eye movement monitor. 886.1570 Ophthalmoscope. 886.1605 Perimeter. 886.1630 AC-powered photostimulator. 886.1640 Ophthalmic preamplifier. 886.1650 Ophthalmic bar prism. 886.1655 Ophthalmic Fresnel prism. 886.1660 Gonioscopic prism. 886.1665 Ophthalmic rotary prism. 886.1670 Ophthalmic isotope uptake probe. 886.1680 Ophthalmic projector. 886.1690 Pupillograph. 886.1700 Pupillometer. 886.1750 Skiascopic rack. 886.1760 Ophthalmic refractometer. 886.1770 Manual refractor. 886.1780 Retinoscope. 886.1790 Nearpoint ruler. 886.1800 Schirmer strip. 886.1810 Tangent screen (campimeter). 886.1840 Simulatan (including crossed cyl

inder). 886.1850 AC-powered slitlamp biomicro

scope. 886.1860 Ophthalmic instrument stand. 886.1870 Stereoscope. 886.1880 Fusion and stereoscopic target. 886.1905 Nystagmus tape. 886.1910 Spectacle dissociation test system. 886.1930 Tonometer and accessories. 886.1940 Tonometer sterilizer. 886.1945 Transilluminator.

Subpart E-Surgical Devices 886.4070 Powered corneal burr. 886.4100 Radiofrequency electrosurgical cau

tery apparatus. 886.4115 Thermal cautery unit. 886.4150 Vitreous aspiration and cutting in

strument. 886.4170 Cryophthalmic unit. 886.4230 Ophthalmic knife test drum. 886.4250 Ophthalmic electrolysis unit. 886.4270 Intraocular gas. 886.4275 Intraocular fluid. 886.4280 Intraocular pressure measuring de

vice. 886.4300 Intraocular lens guide. 886.4335 Operating headlamp. 886.4350 Manual ophthalmic surgical instru

ment. 886.4360 Ocular surgery irrigation device. 886.4370 Keratome. 886.4390 Ophthalmic laser. 886.4392 Nd:YAG laser for posterior

capsulotomy and peripheral iridotomy. 886.4400 Electronic metal locator. 886.4440 AC-powered magnet. 886.4445 Permanent magnet. 886.4570 Ophthalmic surgical marker. 886.4610 Ocular pressure applicator. 886.4670 Phacofragmentation system. 886.4690 Ophthalmic photocoagulator. 886.4750 Ophthalmic eye shield. 886.4770 Ophthalmic operating spectacles

(loupes). 886.4790 Ophthalmic sponge. 886.4855 Ophthalmic instrument table.

Subpart F-Therapeutic Devices 886.5100 Ophthalmic beta radiation source. 886.5120 Low-power binocular loupe. 886.5420 Contact lens inserter/remover. 886.5540 Low-vision magnifier. 886.5600 Ptosis crutch. 886.5800 Ophthalmic bar reader. 886.5810 Ophthalmic prism reader. 886.5820 Closed-circuit television reading

system. 886.5840 Magnifying spectacles. 886.5842 Spectacle frame. 886.5844 Prescription spectacle lens. 886.5850 Sunglasses (nonprescription). 886.5870 Low-vision telescope. 886.5900 Electronic vision aid. 886.5910 Image intensification vision aid. 886.5915 Optical vision aid. 886.5916 Rigid gas permeable contact lens. 886.5918 Rigid gas permeable contact lens

care products. 886.5925 Soft (hydrophilic) contact lens. 886.5928 Soft (hydrophilic) contact lens care

products. 886.5933 [Reserved]

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

SOURCE: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

Subpart C (Reserved)

Subpart D-Prosthetic Devices

886.3100 Ophthalmic tantalum clip. 886.3130 Ophthalmic conformer. 886.3200 Artificial eye. 886.3300 Absorbable implant (scleral buck

ling method). 886.3320 Eye sphere implant. 886.3340 Extraocular orbital implant. 886.3400 Keratoprosthesis. 886.3600 Intraocular lens. 886.3800 Scleral shell. 886.3920 Aqueous shunt.

Subpart A-General Provisions

8 886.1 Scope.

(a) This part sets forth the classification of ophthalmic 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 ophthalmic 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.

tive 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.

(c) A device identified in a regulation in this part that is classified into class III and that is subject to the transitional provisions of section 520(1) of the act is automatically classified by statute into class III and must have an approval under section 515 of the act before being commercially distributed. Accordingly, the regulation for such a class III transitional 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.

8 886.3 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 gr ted 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 paragraphs (b) and (c) of this section. Such a regulation under section 515(b) of the act shall not be effec

ac

life-threatening diseases such as quired 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 2320, Jan. 14, 2000]

Subpart B-Diagnostic Devices

8886.9 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

surrogate marker for screening, diagnosis, or monitoring

8886.1040 Ocular esthesiometer.

(a) Identification An ocular esthesiometer is a device, such as a single-hair brush, intended to touch the cornea to assess corneal sensitivity.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

(52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 59 FR 63012, Dec. 7, 1994]

8886.1050 Adaptometer (biophotom

eter). (a) Identification. An adaptometer (biophotometer) is an AC-powered device that provides a stimulating light source which has various controlled intensities intended to measure the time required for retinal adaptation (regeneration of the visual purple) and the minimum light threshold.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994)

as

a

$820.198, with respect to complaint files. [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994)

$886.1070 Anomaloscope.

(a) Identification. An anomaloscope is an AC-powered device intended to test for anomalies of color vision by displaying mixed spectral lines to be matched by the patient.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994)

8886.1090 Haidlinger brush.

(a) Identification. A Haidlinger brush is an AC-powered device that provides two conical brushlike images with apexes touching which are viewed by the patient through a Nicol prism and intended to evaluate visual function. It may include a component for measuring macular integrity.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994)

8886.1150 Visual acuity chart.

(a) Identification. A visual acuity chart is a device that is a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter. The device 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 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 53 FR 40825, Oct. 18, 1988)

8886.1120 Opthalmic camera.

(a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

(b) Classification. Class II.

8 886.1160 Color vision plate illu

minator. (a) Identification. A color vision plate illuminator is an AC-powered device that is a lamp intended to properly illuminate color vision testing plates. It may include a filter.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994)

(55 FR 48441, Nov. 20, 1990)

8886.1140 Ophthalmic chair.

(a) Identification. An ophthalmic chair is an AC-powered or manual device with adjustable positioning in which a patient is to sit or recline during ophthalmological examination or treatment.

(b) Classification. Class I. The ACpowered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter. The manual device is also 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

$886.1170 Color vision tester.

(a) Identification. A color vision tester is a device that consists of various colored materials, such as colored yarns or color vision plates (multicolored plates which patients with color vision deficiency would perceive as being of one color), intended to evaluate color vision.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter. The device 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

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