21 CFR 882.1200
§ 882.1200 Two-point discriminator.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 882.1200, § 882.1200 Two-point discriminator, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90629
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.