eCFR Reference Browser

---

title: "21 CFR §878.3300"

source: "https://www.ecfr.gov/current/title-21/section-878.3300"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "878"

part_subject: "GENERAL AND PLASTIC SURGERY DEVICES"

subpart_code: "D"

subpart_subject: "Prosthetic Devices"

section_number: "878.3300"

section_subject: "Surgical mesh."

cfr_reference: "21 CFR 878.3300"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

(b)Classification. Class II.

§878.3300 - Surgical mesh.