StacksVerified U.S. regulatory reference

21 CFR §882.5910

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).
  2. (b)Classification. Class II (performance standards).