21 CFR § 878.4520 - Polytetrafluoroethylene injectable.

---
identifier: "/us/cfr/t21/s878.4520"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 878.4520 - Polytetrafluoroethylene injectable."
title_number: 21
title_name: "Food and Drugs"
section_number: "878.4520"
section_name: "Polytetrafluoroethylene injectable."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "878"
part_name: "GENERAL AND PLASTIC SURGERY 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: "53 FR 23872, June 24, 1988, unless otherwise noted."
cfr_part: "878"
---


# 878.4520 Polytetrafluoroethylene injectable.

(a) *Identification.* Polytetrafluoroethylene injectable is an injectable paste prosthetic device composed of polytetrafluoroethylene intended to be used to augment or reconstruct a vocal cord.

(b) *Classification.* Class III.

(c) *Date PMA or notice of completion of a PDP is required.* As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3.