21 CFR § 874.3430 - Middle ear mold.

---
identifier: "/us/cfr/t21/s874.3430"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 874.3430 - Middle ear mold."
title_number: 21
title_name: "Food and Drugs"
section_number: "874.3430"
section_name: "Middle ear mold."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "874"
part_name: "EAR, NOSE, AND THROAT 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: "51 FR 40389, Nov. 6, 1986, unless otherwise noted."
cfr_part: "874"
---


# 874.3430 Middle ear mold.

(a) *Identification.* A middle ear mold is a preformed device that is intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane. The device permits an ample air-filled cavity to be maintained in the middle ear and promotes regeneration of the mucous membrane lining of the middle ear cavity. A middle ear mold is made of materials such as polyamide, polytetrafluoroethylene, silicone elastomer, or polyethylene, but does not contain porous polyethylene.

(b) *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]