21 CFR § 874.3620 - Ear, nose, and throat synthetic polymer material.

---
identifier: "/us/cfr/t21/s874.3620"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 874.3620 - Ear, nose, and throat synthetic polymer material."
title_number: 21
title_name: "Food and Drugs"
section_number: "874.3620"
section_name: "Ear, nose, and throat synthetic polymer material."
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"
---


# 874.3620 Ear, nose, and throat synthetic polymer material.

(a) *Identification.* Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

(b) *Classification.* Class II.