21 CFR § 888.4150 - Calipers for clinical use.

---
identifier: "/us/cfr/t21/s888.4150"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 888.4150 - Calipers for clinical use."
title_number: 21
title_name: "Food and Drugs"
section_number: "888.4150"
section_name: "Calipers for clinical use."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "888"
part_name: "ORTHOPEDIC 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: "52 FR 33702, Sept. 4, 1987, unless otherwise noted."
cfr_part: "888"
---


# 888.4150 Calipers for clinical use.

(a) *Identification.* A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.

(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 the limitations in § 888.9.

[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]