21 CFR § 890.3675 - Denis Brown splint.

---
identifier: "/us/cfr/t21/s890.3675"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 890.3675 - Denis Brown splint."
title_number: 21
title_name: "Food and Drugs"
section_number: "890.3675"
section_name: "Denis Brown splint."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "890"
part_name: "PHYSICAL MEDICINE 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: "48 FR 53047, Nov. 23, 1983, unless otherwise noted."
cfr_part: "890"
---


# 890.3675 Denis Brown splint.

(a) *Identification.* A Denis Brown splint is a device intended for medical purposes to immobilize the foot. It is used on young children with tibial torsion (excessive rotation of the lower leg) or club foot.

(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 § 890.9. 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.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001; 90 FR 55994, Dec. 4, 2025]