21 CFR § 882.1200 - Two-point discriminator.
---
identifier: "/us/cfr/t21/s882.1200"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 882.1200 - Two-point discriminator."
title_number: 21
title_name: "Food and Drugs"
section_number: "882.1200"
section_name: "Two-point discriminator."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "882"
part_name: "NEUROLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "44 FR 51730, Sept. 4, 1979, unless otherwise noted."
cfr_part: "882"
---
# 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 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
[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]