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Food and Drug Administration, HHS § 886.1200

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Food and Drug Administration, HHS § 886.1200 Food and Drug Administration, HHS § 886.1200 § 820.198, with respect to complaint subject to the limitations in § 886.9. The files. device is also exempt from the current good manufacturing practice require- [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, ments of the quality system regulation 2001] in part 820 of this chapter, with the ex- ception of § 820.180, with respect to gen- § 886.1150 Visual acuity chart. eral requirements concerning records, (a) Identification. A visual acuity and § 820.198, with respect to complaint chart is a device that is a chart, such files. as a Snellen chart with block letters or [52 FR 33355, Sept. 2, 1987, as amended at 53 other symbols in graduated sizes, in- FR 35603, Sept. 14, 1988; 66 FR 38810, July 25, tended to test visual acuity. 2001] (b) Classification. Class I (general con- trols). The device is exempt from the § 886.1190 Distometer. premarket notification procedures in (a) Identification. A distometer is a subpart E of part 807 of this chapter, device intended to measure the dis- subject to the limitations in § 886.9. The tance between the cornea and a correc- device is also exempt from the current tive lens during refraction to help good manufacturing practice require- measure the change of the visual image ments of the quality system regulation when a lens is in place. in part 820 of this chapter, with the ex- ception of § 820.180, with respect to gen- (b) Classification. Class I (general con- eral requirements concerning records, trols). The device is exempt from the and § 820.198, with respect to complaint premarket notification procedures in files. subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The [52 FR 33355, Sept. 2, 1987, as amended at 53 device is also exempt from the current FR 35603, Sept. 14, 1988; 53 FR 40825, Oct. 18, good manufacturing practice require- 1988; 66 FR 38810, July 25, 2001] ments of the quality system regulation § 886.1160 Color vision plate illu- in part 820 of this chapter, with the ex- minator. ception of § 820.180, with respect to gen- eral requirements concerning records, (a) Identification. A color vision plate and § 820.198, with respect to complaint illuminator is an AC-powered device files. that is a lamp intended to properly il- luminate color vision testing plates. It [52 FR 33355, Sept. 2, 1987, as amended at 53 may include a filter. FR 35603, Sept. 14, 1988; 66 FR 38810, July 25, (b) Classification. Class I (general con- 2001] trols). The device is exempt from the premarket notification procedures in § 886.1200 Optokinetic drum. subpart E of part 807 of this chapter, (a) Identification. An optokinetic subject to the limitations in § 886.9. drum is a drum-like device covered [55 FR 48441, Nov. 20, 1990, as amended at 59 with alternating white and dark stripes FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, or pictures that can be rotated on its 2001] handle. The device is intended to elicit and evaluate nystagmus (involuntary § 886.1170 Color vision tester. rapid movement of the eyeball) in pa- (a) Identification. A color vision tester tients. is a device that consists of various col- (b) Classification. Class I (general con- ored materials, such as colored yarns trols). The device is exempt from the or color vision plates (multicolored premarket notification procedures in plates which patients with color vision subpart E of part 807 of this chapter, deficiency would perceive as being of subject to the limitations in § 886.9. The one color), intended to evaluate color device is also exempt from the current vision. good manufacturing practice require- (b) Classification. Class I (general con- ments of the quality system regulation trols). The device is exempt from the in part 820 of this chapter, with the ex- premarket notification procedures in ception of § 820.180, with respect to gen- subpart E of part 807 of this chapter, eral requirements concerning records, 473 VerDate Nov<24>2008 08:24 Apr 27, 2010 Jkt 220072 PO 00000 Frm 00483 Fmt 8010 Sfmt 8010 Y:\SGML\220072.XXX 220072 erowe on DSK5CLS3C1PROD with CFR § 886.1220 21 CFR Ch. I (4–1–10 Edition) and § 820.198, with respect to complaint subpart E of part 807 of this chapter, files. subject to the limitations in § 886.9. [52 FR 33355, Sept. 2, 1987, as amended at 53 [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, 2001] 2001] § 886.1220 Corneal electrode. § 886.1290 Fixation device. (a) Identification. A corneal electrode (a) Identification. A fixation device is is an AC-powered device, usually part an AC-powered device intended for use of a special contact lens, intended to be as a fixation target for the patient dur- applied directly to the cornea to pro- ing ophthalmological examination. The vide data showing the changes in elec- patient directs his or her gaze so that trical potential in the retina after the visual image of the object falls on electroretinography (stimulation by the fovea centralis (the center of the light). macular retina of the eye.) (b) Classification. Class II. (b) Classification. Class I (general con- trols). The device is exempt from the § 886.1250 Euthyscope. premarket notification procedures in (a) Identification. A euthyscope is a subpart E of part 807 of this chapter, device that is a modified AC-powered subject to the limitations in § 886.9. or battery-powered ophthalmoscope (a [55 FR 48441, Nov. 20, 1990, as amended at 59 perforated mirror device intended to FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, inspect the interior of the eye) that 2001] projects a bright light encompassing an arc of about 30 degrees onto the fundus § 886.1300 Afterimage flasher. of the eye. The center of the light bun- (a) Identification. An afterimage dle is blocked by a black disk covering flasher is an AC-powered light that the fovea (the central depression of the automatically switches on and off to macular retinae where only cones are allow performance of an afterimage present and blood vessels are lacking). test in which the patient indicates the The device is intended for use in the positions of afterimages after the light treatment of amblyopia (dimness of vi- is off. The device is intended to deter- sion without apparent disease of the mine harmonious/anomalous retinal eye). correspondence (the condition in which (b) Classification. Class I for the bat- corresponding points on the retina tery powered device. The battery pow- have the same directional value). ered device is exempt from the pre- (b) Classification. Class II. market notification procedures in sub- part E of part 807 of this chapter, sub- [55 FR 48441, Nov. 20, 1990] ject to the limitations in § 886.9. Class § 886.1320 Fornixscope. II for the AC-powered device. (a) Identification. A fornixscope is a [55 FR 48441, Nov. 20, 1990, as amended at 59 device intended to pull back and hold FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001] open the eyelid to aid examination of the conjunctiva. § 886.1270 Exophthalmometer. (b) Classification. Class I (general con- trols). The device is exempt from the (a) Identification. An premarket notification procedures in exophthalmometer is a device, such as subpart E of part 807 of this chapter, a ruler, gauge, or caliper, intended to subject to the limitations in § 886.9. The measure the degree of exophthalmos device is also exempt from the current (abnormal protrusion of the eyeball). good manufacturing practice require- (b) Classification. Class I (general con- ments of the quality system regulation trols). The device is exempt from the in part 820 of this chapter, with the ex- premarket notification procedures in ception of § 820.180, with respect to gen- eral requirements concerning records, 474 VerDate Nov<24>2008 08:24 Apr 27, 2010 Jkt 220072 PO 00000 Frm 00484 Fmt 8010 Sfmt 8010 Y:\SGML\220072.XXX 220072 erowe on DSK5CLS3C1PROD with CFR.
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