StacksVerified U.S. regulatory reference

21 CFR §878.3590

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.
  2. (b)Classification. Class II.