---
kind: "section"
citation: "21 C.F.R. § 886.1605"
title: "21"
number: "886.1605"
heading: "Perimeter."
url: "https://uscodex.org/cfr/21/886.1605"
---

# §886.1605. Perimeter.

- (a) **Identification.** A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
- (b) **Classification.** Class I (general controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter, subject to the limitations in [§ 886.9](/cfr/21/886.9.md). The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in [part 820](/cfr/21/part820.md) of this chapter, except for requirements concerning records and complaint files under [§ 820.35](/cfr/21/820.35.md) of this chapter.

## Notes

### Amendments

[55 FR 48442, Nov. 20, 1990, as amended at 66 FR 38811, July 25, 2001; 90 FR 55990, Dec. 4, 2025]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

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

### Amendments

[55 FR 48442, Nov. 20, 1990, as amended at 66 FR 38811, July 25, 2001; 90 FR 55990, Dec. 4, 2025]