Title 21 Part 886 → Subpart B → §886.1810

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1810

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1810

e-CFR data is current as of June 4, 2020

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1810

Title 21: Food and Drugs
Subpart B—Diagnostic Devices

§886.1810   Tangent screen (campimeter).

(a) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square cloth chart with a central mark of fixation intended to map on a flat surface the central 30 degrees of a patient's visual field. This generic type of device includes projection tangent screens, target tangent screens and targets, felt tangent screens, and stereo campimeters.

(b) Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §886.9. The battery-powered device is also 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.

[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001]