Regulations last checked for updates: May 01, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
§ 878.3300 - Surgical mesh.

(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.

authority: 21 U.S.C. 351,360,360c,360e,360j,360l,371
source: 53 FR 23872, June 24, 1988, unless otherwise noted.
cite as: 21 CFR 878.3300