---
kind: "section"
citation: "21 C.F.R. § 882.1200"
title: "21"
number: "882.1200"
heading: "Two-point discriminator."
url: "https://uscodex.org/cfr/21/882.1200"
---

# §882.1200. Two-point discriminator.

- (a) **Identification.** A two-point discriminator is a device with points used for testing a patient's touch discrimination.
- (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 [§ 882.9](/cfr/21/882.9.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

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000; 90 FR 55989, Dec. 4, 2025]

### Authority

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

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

[44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000; 90 FR 55989, Dec. 4, 2025]